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FDA 510(k)

BICEPS ELECTROCAUTERY SYSTEM

K-Number: K823755 · 1983-01-26

ApplicantSquibb Diagnostics
Decision Date1983-01-26
Product CodeHAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BICEPS ELECTROCAUTERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Squibb Diagnostics. It received FDA 510(k) clearance on 1983-01-26 under 510(k) number K823755. The device is classified under product code HAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BICEPS ELECTROCAUTERY SYSTEM?

BICEPS ELECTROCAUTERY SYSTEM is a medical device that received FDA 510(k) clearance on 1983-01-26. The listed applicant is Squibb Diagnostics. The 510(k) number is K823755.

When did BICEPS ELECTROCAUTERY SYSTEM receive FDA 510(k) clearance?

BICEPS ELECTROCAUTERY SYSTEM received FDA 510(k) clearance on 1983-01-26, under 510(k) number K823755.

Who is the listed applicant for BICEPS ELECTROCAUTERY SYSTEM?

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

What is the FDA product code for BICEPS ELECTROCAUTERY SYSTEM?

The FDA product code for BICEPS ELECTROCAUTERY SYSTEM is HAM.

Related Clinical Trials

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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Other records listing Squibb Diagnostics 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.

K883609ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATORK842568RADIONUCLIDE INFUSION SYSTEM

Related Devices (Code: HAM)

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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