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FDA 510(k)

ZEE MANUAL RESUSCITATOR

K-Number: K812022 · 1981-07-31

ApplicantZee Medical Products Co., Inc.
Decision Date1981-07-31
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ZEE MANUAL RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Zee Medical Products Co., Inc.. It received FDA 510(k) clearance on 1981-07-31 under 510(k) number K812022. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEE MANUAL RESUSCITATOR?

ZEE MANUAL RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1981-07-31. The listed applicant is Zee Medical Products Co., Inc.. The 510(k) number is K812022.

When did ZEE MANUAL RESUSCITATOR receive FDA 510(k) clearance?

ZEE MANUAL RESUSCITATOR received FDA 510(k) clearance on 1981-07-31, under 510(k) number K812022.

Who is the listed applicant for ZEE MANUAL RESUSCITATOR?

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

What is the FDA product code for ZEE MANUAL RESUSCITATOR?

The FDA product code for ZEE MANUAL RESUSCITATOR is BTM.

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Other records listing Zee Medical Products Co., 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.

K823501ZEE SPHYGMOMANOMETERK813156ULTRA-WIDE SAFETY SPECTACLE FRAMEK813016ZEE TRACTION SPLINTK812814ZEE SURGICAL INSTRUMENTSK812564ZEE LIFE SUPPORT AIR PANTSK812342ZEE EXTRICATION DEVICE

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Related Devices (Code: BTM)

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.

K251631The BAG manual resuscitator and accessoriesLaerdal Medical ASK243861butterflyBVMCompact Medical, Inc.K221841EOlife®ArcheonK212905Sotair DeviceSafe Bvm CorporationK210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20Flexicare Medical Limited.

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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