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FDA 510(k)

RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR

K-Number: K855108 · 1986-02-21

ApplicantBiomaterials International, Inc.
Decision Date1986-02-21
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR is the device name listed in this FDA 510(k) record. The listed applicant is Biomaterials International, Inc.. It received FDA 510(k) clearance on 1986-02-21 under 510(k) number K855108. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR?

RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR is a medical device that received FDA 510(k) clearance on 1986-02-21. The listed applicant is Biomaterials International, Inc.. The 510(k) number is K855108.

When did RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR receive FDA 510(k) clearance?

RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR received FDA 510(k) clearance on 1986-02-21, under 510(k) number K855108.

Who is the listed applicant for RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR?

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

What is the FDA product code for RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR?

The FDA product code for RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR is JJQ.

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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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