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FDA 510(k)

THERMASCAN

K-Number: K813547 · 1982-03-12

ApplicantBcd Products, Inc.
Decision Date1982-03-12
Product CodeKXZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THERMASCAN is the device name listed in this FDA 510(k) record. The listed applicant is Bcd Products, Inc.. It received FDA 510(k) clearance on 1982-03-12 under 510(k) number K813547. The device is classified under product code KXZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMASCAN?

THERMASCAN is a medical device that received FDA 510(k) clearance on 1982-03-12. The listed applicant is Bcd Products, Inc.. The 510(k) number is K813547.

When did THERMASCAN receive FDA 510(k) clearance?

THERMASCAN received FDA 510(k) clearance on 1982-03-12, under 510(k) number K813547.

Who is the listed applicant for THERMASCAN?

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

What is the FDA product code for THERMASCAN?

The FDA product code for THERMASCAN is KXZ.

Related Clinical Trials

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Other records listing Bcd Products, 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.

K831773MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK

Related Devices (Code: KXZ)

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.

K851034NOVATHERMMedtech Products, Inc.K843124Q-SCAN THERMOGRAPHY SYSTEMQmax Medical, Inc.K832731BREAST & BODY HEALTH SYSTEM 2000American Thermal Instruments, Inc.K781916FLEXT-THERME-Z-Em, Inc.K770986FLEXI-THERM FILME-Z-Em, Inc.K770678ELC-THERMO-SYSTEMCutter Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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