Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016490024

FEI Number

3016490024

Entity Name

SENZIME AB

City/State/Country

Uppsala, SE

Establishment Address

Verkstadsgatan 8, Uppsala 75323, SE

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Senzime AB (Owner Number: 10062527)

Owner / Operator Contact Address

Verkstadsgatan 8, Uppsala, SE-C 75323, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K261098

PMA Number

N/A

All Registered Proprietary Names

TetraGraph Neuromuscular Transmission Monitor (NMT)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2023-03-01
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-03-01
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2020-02-07
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2022-09-05
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2026-05-27

Official Correspondent

Johanna Faris

US Agent Details

George Hamilton Email: george.hamilton@senzime.com Phone: (314) 2215634

Related Public Records

Same Entity

Senzime AB

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
K913749	Edentec Corp.	EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170	1992-07-02
K771407	Research Development Corp.	LUNG VOLUME & PRESSURE MONITOR	1977-08-04
K122223	Philips Medizin Systeme Boeblingen GmbH	NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO	2013-04-12

Similar Registrations

Registration Number	Establishment Name	Location
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN
1219324	RESPIRONICS NOVAMETRIX, LLC	Andover, MA, US
3004415070	KB Components Finland Oy	Nurmijarvi Etela-Karjala, FI
3008729547	GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.	JUAREZ Chihuahua, MX
1651104	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES	EL PASO, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016490024. Last updated year: 2026. Please use registration number 3016490024 when referencing this establishment in official correspondence.