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FDA 510(k)

0-20 CM H20 PEEP VALVE

K-Number: K981415 · 1998-07-14

ApplicantCheen Houng Ent. Co. , Ltd.
Decision Date1998-07-14
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

0-20 CM H20 PEEP VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Cheen Houng Ent. Co. , Ltd.. It received FDA 510(k) clearance on 1998-07-14 under 510(k) number K981415. 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 0-20 CM H20 PEEP VALVE?

0-20 CM H20 PEEP VALVE is a medical device that received FDA 510(k) clearance on 1998-07-14. The listed applicant is Cheen Houng Ent. Co. , Ltd.. The 510(k) number is K981415.

When did 0-20 CM H20 PEEP VALVE receive FDA 510(k) clearance?

0-20 CM H20 PEEP VALVE received FDA 510(k) clearance on 1998-07-14, under 510(k) number K981415.

Who is the listed applicant for 0-20 CM H20 PEEP VALVE?

The FDA 510(k) record lists Cheen Houng Ent. Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 0-20 CM H20 PEEP VALVE?

The FDA product code for 0-20 CM H20 PEEP VALVE is BYE.

Related Clinical Trials

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.

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Other records listing Cheen Houng Ent. Co. , Ltd. 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.

K121587BREATH SHAKEK021390PMX COMPACT RESUCITATORK003927Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02K010191Y2000 POCKET RESCUEK970688POCKET RESCUE

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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