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FDA 510(k)

PEEP SYSTEM D

K-Number: K831301 · 1983-06-08

ApplicantDraeger Medical, Inc.
Decision Date1983-06-08
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEEP SYSTEM D is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831301. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEP SYSTEM D?

PEEP SYSTEM D is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Draeger Medical, Inc.. The 510(k) number is K831301.

When did PEEP SYSTEM D receive FDA 510(k) clearance?

PEEP SYSTEM D received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831301.

Who is the listed applicant for PEEP SYSTEM D?

The FDA 510(k) record lists Draeger Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEEP SYSTEM D?

The FDA product code for PEEP SYSTEM D is BYE.

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Other records listing Draeger Medical, Inc. 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.

K042607PRIMUS USK042419FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEMK042276D-VAPORK042086FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMK041622MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMK040847MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR

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Related Devices (Code: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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