FDA 510(k)

ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522

K-Number: K982216 · 1998-09-11

Decision Date1998-09-11

Product CodeBZQ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 is the device name listed in this FDA 510(k) record. The listed applicant is Braebon Medical Corp.. It received FDA 510(k) clearance on 1998-09-11 under 510(k) number K982216. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522?

ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 is a medical device that received FDA 510(k) clearance on 1998-09-11. The listed applicant is Braebon Medical Corp.. The 510(k) number is K982216.

When did ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 receive FDA 510(k) clearance?

ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 received FDA 510(k) clearance on 1998-09-11, under 510(k) number K982216.

Who is the listed applicant for ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522?

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

What is the FDA product code for ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522?

The FDA product code for ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 is BZQ.

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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.