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FDA 510(k)

BOVAC SMOKE COLLECTOR

K-Number: K884641 · 1988-12-22

ApplicantOrthopedic Systems, Inc.
Decision Date1988-12-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOVAC SMOKE COLLECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1988-12-22 under 510(k) number K884641. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOVAC SMOKE COLLECTOR?

BOVAC SMOKE COLLECTOR is a medical device that received FDA 510(k) clearance on 1988-12-22. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K884641.

When did BOVAC SMOKE COLLECTOR receive FDA 510(k) clearance?

BOVAC SMOKE COLLECTOR received FDA 510(k) clearance on 1988-12-22, under 510(k) number K884641.

Who is the listed applicant for BOVAC SMOKE COLLECTOR?

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

What is the FDA product code for BOVAC SMOKE COLLECTOR?

The FDA product code for BOVAC SMOKE COLLECTOR is GEI.

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Other records listing Orthopedic Systems, Inc. as applicant

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Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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