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FDA 510(k)

HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.

K-Number: K875077 · 1988-01-19

ApplicantHerco Products, Inc.
Decision Date1988-01-19
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA. is the device name listed in this FDA 510(k) record. The listed applicant is Herco Products, Inc.. It received FDA 510(k) clearance on 1988-01-19 under 510(k) number K875077. 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 HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.?

HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA. is a medical device that received FDA 510(k) clearance on 1988-01-19. The listed applicant is Herco Products, Inc.. The 510(k) number is K875077.

When did HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA. receive FDA 510(k) clearance?

HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA. received FDA 510(k) clearance on 1988-01-19, under 510(k) number K875077.

Who is the listed applicant for HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.?

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

What is the FDA product code for HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.?

The FDA product code for HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA. is BTM.

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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

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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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