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FDA 510(k)

THE BERG RESUSCITATION APPARATUS

K-Number: K882833 · 1988-08-19

Decision Date1988-08-19
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE BERG RESUSCITATION APPARATUS is the device name listed in this FDA 510(k) record. The listed applicant is Hursch Ent., Inc.. It received FDA 510(k) clearance on 1988-08-19 under 510(k) number K882833. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE BERG RESUSCITATION APPARATUS?

THE BERG RESUSCITATION APPARATUS is a medical device that received FDA 510(k) clearance on 1988-08-19. The listed applicant is Hursch Ent., Inc.. The 510(k) number is K882833.

When did THE BERG RESUSCITATION APPARATUS receive FDA 510(k) clearance?

THE BERG RESUSCITATION APPARATUS received FDA 510(k) clearance on 1988-08-19, under 510(k) number K882833.

Who is the listed applicant for THE BERG RESUSCITATION APPARATUS?

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

What is the FDA product code for THE BERG RESUSCITATION APPARATUS?

The FDA product code for THE BERG RESUSCITATION APPARATUS is BTL.

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.

Related Devices (Code: BTL)

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.

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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