Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TMR48

K-Number: K953342 · 1995-09-08

Decision Date1995-09-08
Product CodeINO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TMR48 is the device name listed in this FDA 510(k) record. The listed applicant is Pride Health Care, Inc.. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K953342. The device is classified under product code INO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMR48?

TMR48 is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Pride Health Care, Inc.. The 510(k) number is K953342.

When did TMR48 receive FDA 510(k) clearance?

TMR48 received FDA 510(k) clearance on 1995-09-08, under 510(k) number K953342.

Who is the listed applicant for TMR48?

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

What is the FDA product code for TMR48?

The FDA product code for TMR48 is INO.

Other records listing Pride Health Care, 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.

View all 19 devices →

Related Devices (Code: INO)

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.

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.

↑