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FDA 510(k)

BARO-GRAF 24

K-Number: K881297 · 1988-09-16

ApplicantInstromedix, Inc.
Decision Date1988-09-16
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BARO-GRAF 24 is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1988-09-16 under 510(k) number K881297. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARO-GRAF 24?

BARO-GRAF 24 is a medical device that received FDA 510(k) clearance on 1988-09-16. The listed applicant is Instromedix, Inc.. The 510(k) number is K881297.

When did BARO-GRAF 24 receive FDA 510(k) clearance?

BARO-GRAF 24 received FDA 510(k) clearance on 1988-09-16, under 510(k) number K881297.

Who is the listed applicant for BARO-GRAF 24?

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

What is the FDA product code for BARO-GRAF 24?

The FDA product code for BARO-GRAF 24 is DRS.

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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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