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FDA 510(k)

BIONICA MDS 110 PCA

K-Number: K875316 · 1988-05-11

ApplicantBionica, Inc.
Decision Date1988-05-11
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIONICA MDS 110 PCA is the device name listed in this FDA 510(k) record. The listed applicant is Bionica, Inc.. It received FDA 510(k) clearance on 1988-05-11 under 510(k) number K875316. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIONICA MDS 110 PCA?

BIONICA MDS 110 PCA is a medical device that received FDA 510(k) clearance on 1988-05-11. The listed applicant is Bionica, Inc.. The 510(k) number is K875316.

When did BIONICA MDS 110 PCA receive FDA 510(k) clearance?

BIONICA MDS 110 PCA received FDA 510(k) clearance on 1988-05-11, under 510(k) number K875316.

Who is the listed applicant for BIONICA MDS 110 PCA?

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

What is the FDA product code for BIONICA MDS 110 PCA?

The FDA product code for BIONICA MDS 110 PCA is FRN.

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Other records listing Bionica, Inc. as applicant

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.

K895426AMBULATORY INFUSION PUMPK864276PERSONAL INFUSION PUMP

Related Devices (Code: FRN)

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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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