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FDA 510(k)

BIOSCOPE

K-Number: K923406 · 1993-09-22

ApplicantBiotronik, GmbH & Co.
Decision Date1993-09-22
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, GmbH & Co.. It received FDA 510(k) clearance on 1993-09-22 under 510(k) number K923406. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSCOPE?

BIOSCOPE is a medical device that received FDA 510(k) clearance on 1993-09-22. The listed applicant is Biotronik, GmbH & Co.. The 510(k) number is K923406.

When did BIOSCOPE receive FDA 510(k) clearance?

BIOSCOPE received FDA 510(k) clearance on 1993-09-22, under 510(k) number K923406.

Who is the listed applicant for BIOSCOPE?

The FDA 510(k) record lists Biotronik, GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSCOPE?

The FDA product code for BIOSCOPE is DPS.

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Other records listing Biotronik, GmbH & Co. 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.

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Related Devices (Code: DPS)

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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