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FDA 510(k)

BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR

K-Number: K934310 · 1993-12-14

ApplicantRespironics, Inc.
Decision Date1993-12-14
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1993-12-14 under 510(k) number K934310. 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 BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR?

BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1993-12-14. The listed applicant is Respironics, Inc.. The 510(k) number is K934310.

When did BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR receive FDA 510(k) clearance?

BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR received FDA 510(k) clearance on 1993-12-14, under 510(k) number K934310.

Who is the listed applicant for BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR?

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

What is the FDA product code for BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR?

The FDA product code for BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR is BTM.

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Related Devices (Code: BTM)

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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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