FDA 510(k)

HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR

K-Number: K964719 · 1997-02-21

Decision Date1997-02-21

Product CodeBTM

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Respiratory Care, Inc.. It received FDA 510(k) clearance on 1997-02-21 under 510(k) number K964719. 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 HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR?

HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1997-02-21. The listed applicant is Hudson Respiratory Care, Inc.. The 510(k) number is K964719.

When did HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR receive FDA 510(k) clearance?

HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR received FDA 510(k) clearance on 1997-02-21, under 510(k) number K964719.

Who is the listed applicant for HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR?

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

What is the FDA product code for HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR?

The FDA product code for HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR is BTM.

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Other records listing Hudson Respiratory Care, Inc. as applicant

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Related Devices (Code: BTM)

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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.