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FDA 510(k)

TYPE INTERFACE 9271/1 INCUBATOR/WARMER

K-Number: K912000 · 1992-09-21

ApplicantS & W Medico Teknik
Decision Date1992-09-21
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TYPE INTERFACE 9271/1 INCUBATOR/WARMER is the device name listed in this FDA 510(k) record. The listed applicant is S & W Medico Teknik. It received FDA 510(k) clearance on 1992-09-21 under 510(k) number K912000. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYPE INTERFACE 9271/1 INCUBATOR/WARMER?

TYPE INTERFACE 9271/1 INCUBATOR/WARMER is a medical device that received FDA 510(k) clearance on 1992-09-21. The listed applicant is S & W Medico Teknik. The 510(k) number is K912000.

When did TYPE INTERFACE 9271/1 INCUBATOR/WARMER receive FDA 510(k) clearance?

TYPE INTERFACE 9271/1 INCUBATOR/WARMER received FDA 510(k) clearance on 1992-09-21, under 510(k) number K912000.

Who is the listed applicant for TYPE INTERFACE 9271/1 INCUBATOR/WARMER?

The FDA 510(k) record lists S & W Medico Teknik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TYPE INTERFACE 9271/1 INCUBATOR/WARMER?

The FDA product code for TYPE INTERFACE 9271/1 INCUBATOR/WARMER is FMZ.

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Other records listing S & W Medico Teknik as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K9409339267 SPO2 ATHENA MODULEK913013TCPO2 9260 MODULE - SYSTEM ATHENAK915633MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENAK9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NTK9234189293/1 INTERFACE MODULEK911611SYSTEM ATHENA, MODIFICATION

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Related Devices (Code: FMZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaAK251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K243437mOm Essential Incubator (ME1)Mom Incubators LimitedK213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494Infant IncubatorNingbo David Medical Device Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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