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FDA 510(k)

HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS

K-Number: K841295 · 1984-08-08

ApplicantBow/Parm
Decision Date1984-08-08
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS is the device name listed in this FDA 510(k) record. The listed applicant is Bow/Parm. It received FDA 510(k) clearance on 1984-08-08 under 510(k) number K841295. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS?

HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS is a medical device that received FDA 510(k) clearance on 1984-08-08. The listed applicant is Bow/Parm. The 510(k) number is K841295.

When did HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS receive FDA 510(k) clearance?

HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS received FDA 510(k) clearance on 1984-08-08, under 510(k) number K841295.

Who is the listed applicant for HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS?

The FDA 510(k) record lists Bow/Parm as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS?

The FDA product code for HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS is BTT.

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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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