PROTOTAL Sweden AB

FDA Device Registration & Listing · Jonkoping, SE · Registration 3010526986

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010526986
FEI Number
3010526986
Entity Name
PROTOTAL Sweden AB
City/State/Country
Jonkoping, SE
Establishment Address
Instrumentvaegen 6, Jonkoping 553 02, SE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Prototal Sweden AB (Owner Number: 10045504)
Owner / Operator Contact Address
Instrumentvaegen 6, Joenkoeping, SE-F SE-553 02, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K063752
PMA Number
N/A

All Registered Proprietary Names

Nose Frida Oximeter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2025-12-23
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2013-11-25
DQA Oximeter Cardiovascular Class 2 870.2700 2013-11-25

Official Correspondent

Anita Olsson

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

Prototal Sweden 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
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04
K172904 Philips Medizin Systeme Boeblingen GmbH IntelliVue Capnography Extension, IntelliVue Microstream Extension 2017-12-26
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010526986. Last updated year: 2026. Please use registration number 3010526986 when referencing this establishment in official correspondence.
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