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FDA 510(k)

BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS

K-Number: K940581 · 1994-05-06

ApplicantRespironics, Inc.
Decision Date1994-05-06
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1994-05-06 under 510(k) number K940581. 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 CHILD/INFANT DISPOS MAN RESUSCITATORS?

BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS is a medical device that received FDA 510(k) clearance on 1994-05-06. The listed applicant is Respironics, Inc.. The 510(k) number is K940581.

When did BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS receive FDA 510(k) clearance?

BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS received FDA 510(k) clearance on 1994-05-06, under 510(k) number K940581.

Who is the listed applicant for BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS?

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 CHILD/INFANT DISPOS MAN RESUSCITATORS?

The FDA product code for BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS 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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