FDA 510(k)

MICROSPIRO-SDS

K-Number: K851277 · 1985-04-19

ApplicantMedical Equipment Designs, Inc.

Decision Date1985-04-19

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MICROSPIRO-SDS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Equipment Designs, Inc.. It received FDA 510(k) clearance on 1985-04-19 under 510(k) number K851277. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSPIRO-SDS?

MICROSPIRO-SDS is a medical device that received FDA 510(k) clearance on 1985-04-19. The listed applicant is Medical Equipment Designs, Inc.. The 510(k) number is K851277.

When did MICROSPIRO-SDS receive FDA 510(k) clearance?

MICROSPIRO-SDS received FDA 510(k) clearance on 1985-04-19, under 510(k) number K851277.

Who is the listed applicant for MICROSPIRO-SDS?

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

What is the FDA product code for MICROSPIRO-SDS?

The FDA product code for MICROSPIRO-SDS is BZG.

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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.