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FDA 510(k)

NOVATHERM

K-Number: K851034 · 1985-09-27

ApplicantMedtech Products, Inc.
Decision Date1985-09-27
Product CodeKXZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NOVATHERM is the device name listed in this FDA 510(k) record. The listed applicant is Medtech Products, Inc.. It received FDA 510(k) clearance on 1985-09-27 under 510(k) number K851034. 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 NOVATHERM?

NOVATHERM is a medical device that received FDA 510(k) clearance on 1985-09-27. The listed applicant is Medtech Products, Inc.. The 510(k) number is K851034.

When did NOVATHERM receive FDA 510(k) clearance?

NOVATHERM received FDA 510(k) clearance on 1985-09-27, under 510(k) number K851034.

Who is the listed applicant for NOVATHERM?

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

What is the FDA product code for NOVATHERM?

The FDA product code for NOVATHERM is KXZ.

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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.

K843124Q-SCAN THERMOGRAPHY SYSTEMQmax Medical, Inc.K832731BREAST & BODY HEALTH SYSTEM 2000American Thermal Instruments, Inc.K813547THERMASCANBcd Products, Inc.K781916FLEXT-THERME-Z-Em, Inc.K770986FLEXI-THERM FILME-Z-Em, Inc.K770678ELC-THERMO-SYSTEMCutter Laboratories, Inc.

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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