FDA 510(k)

ERA 2000 EMERGENCY RESUSCITATOR

K-Number: K884089 · 1988-12-20

Decision Date1988-12-20

Product CodeBTL

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ERA 2000 EMERGENCY RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Neotronics Medical , Ltd.. It received FDA 510(k) clearance on 1988-12-20 under 510(k) number K884089. 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 ERA 2000 EMERGENCY RESUSCITATOR?

ERA 2000 EMERGENCY RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1988-12-20. The listed applicant is Neotronics Medical , Ltd.. The 510(k) number is K884089.

When did ERA 2000 EMERGENCY RESUSCITATOR receive FDA 510(k) clearance?

ERA 2000 EMERGENCY RESUSCITATOR received FDA 510(k) clearance on 1988-12-20, under 510(k) number K884089.

Who is the listed applicant for ERA 2000 EMERGENCY RESUSCITATOR?

The FDA 510(k) record lists Neotronics Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERA 2000 EMERGENCY RESUSCITATOR?

The FDA product code for ERA 2000 EMERGENCY RESUSCITATOR is BTL.

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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.