Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2020813

FEI Number

2020813

Entity Name

ACCUTRON, INC.

City/State/Country

PHOENIX, AZ, US

Establishment Address

1625 W Pinnacle Peak Rd, PHOENIX, AZ 85027, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Accutron Inc (Owner Number: 2020813)

Owner / Operator Contact Address

1625 W Pinnacle Peak Rd, Phoenix, AZ 85027, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K910040

PMA Number

N/A

All Registered Proprietary Names

YOKE ASSEMBLY, MEDICAL GAS ACCUTRON Gas-machine, anesthesia ACCUTRON REGULATOR, PRESSURE, GAS CYLINDER BAG, RESERVOIR ACCUTRON Gas-machine, anesthesia Ventilator, emergency, manual (resuscitator)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAM	Yoke Assembly, Medical Gas	Anesthesiology	Class 1	868.6885	2003-10-07
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2005-01-13
CBN	Apparatus, Gas-Scavenging	Anesthesiology	Class 2	868.5430	2016-11-23
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2016-08-02
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2005-01-13
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	1992-06-18
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	1992-06-18
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2005-01-13
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2007-11-28
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-11-28

Official Correspondent

Katy Peterson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Accutron Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780365	Spica, Inc.	OXYGEN/NITROUS OXIDE OUTLET	1978-03-30
K252746	Drägerwerk AG Co. Kgaa	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)	2026-05-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2013	Accutron Inc	2	Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Z-0018-2013	Accutron Inc	2	Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 13627, 13628, 13633, 13634, 13635, 13636, 13637, 13638, 13639, 13640, 13642, 13643, 13644, 13647, 13650, 13669, 13675, 13673, 13678, 13679, 13680, 13683, 13685, 13687, 13691, 13693, 13694, 13695, 13696, 13697, 13701, 13702, 13705, 13706, 13709, 13710, 13711, 13724, 13725, 13728, 13729, 13735, 13739, 13743, 13746, 13750, 13751, 13753, 13754, 13755, 13756, 13760, 13762, 13766, 13774, 13775, 13777, 13781, 13782, 13783, 13785, 13786, 13788, 13792, 13794, 13796, 13799, 13800, 13803, 13804, 13809, 13810, 28298, 28299, 28304, 28305, 28306, 28307, Ultra PC% Cabinet Mount Pkg I, Model #36800, Serial # 13601, 13603, 13607, 13608, 13609, 13613, 13618, 13620, 13623, 13626, 13629, 13630, 13631, 13632, 13641, 13645, 13646, 13648, 13649, 13651, 13652, 13653, 13654, 13655, 13656, 13657, 13658, 13659, 13660, 13661, 13665, 13666, 13667, 13668, 13671, 13672, 13674, 13676, 13677, 13684, 13688, 13689, 13698, 13700, 13707, 13723, 13727, 13730, 13732, 13734, 13741, 13742, 13757, 13758, 13759, 13761, 13762, 13763, 13764, 13765, 13767, 13769, 13789, 13790, 13791, 13795, 13797, 13801, 13802, 13806, 13808, 28300, 28302, 28303, Ultra PC% Cabinet Mount Pkg G, Model#36600-NS, Serial# 13805, 13807, 13811, 13812. Ultra PC% Cabinet Mount Pkg H, Model#36800-NS, Serial# 13744, 13745,13752, 13773, 13774, 13778, 13779, 13780 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Z-0019-2013	Accutron Inc	2	CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Z-0020-2013	Accutron Inc	2	Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.
Z-0008-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2020813. Last updated year: 2026. Please use registration number 2020813 when referencing this establishment in official correspondence.