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FDA 510(k)

POCKET RESCUE

K-Number: K970688 · 1997-09-26

ApplicantCheen Houng Ent. Co. , Ltd.
Decision Date1997-09-26
Product CodeKGB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POCKET RESCUE 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 1997-09-26 under 510(k) number K970688. The device is classified under product code KGB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POCKET RESCUE?

POCKET RESCUE is a medical device that received FDA 510(k) clearance on 1997-09-26. The listed applicant is Cheen Houng Ent. Co. , Ltd.. The 510(k) number is K970688.

When did POCKET RESCUE receive FDA 510(k) clearance?

POCKET RESCUE received FDA 510(k) clearance on 1997-09-26, under 510(k) number K970688.

Who is the listed applicant for POCKET RESCUE?

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 POCKET RESCUE?

The FDA product code for POCKET RESCUE is KGB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 RESCUEK9814150-20 CM H20 PEEP VALVE

Related Devices (Code: KGB)

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.

K960401ULTIMATE SEALHans Rudolph, Inc.K941336COMBO MASKGam Industries, Inc.K935917CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVESBd Becton Dickinson Vacutainer Systems PreanalyticK932347COMPACT MASKVital Signs, Inc.K933583NONREBREATHING VALVEHans Rudolph, Inc.K933048LAERDAL(TM) POCKET MASK, MODIFICATIONLaerdal Medical Corp.

Official Source

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

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