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)

ALGESIOMETER

K-Number: K801907 · 1980-09-16

ApplicantRowan Products, Inc.
Decision Date1980-09-16
Product CodeGXB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ALGESIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Rowan Products, Inc.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801907. The device is classified under product code GXB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALGESIOMETER?

ALGESIOMETER is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Rowan Products, Inc.. The 510(k) number is K801907.

When did ALGESIOMETER receive FDA 510(k) clearance?

ALGESIOMETER received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801907.

Who is the listed applicant for ALGESIOMETER?

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

What is the FDA product code for ALGESIOMETER?

The FDA product code for ALGESIOMETER is GXB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: GXB)

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.

K933798NU-PREP GELCadwell Laboratories, Inc.K871571NEUROTIPS(TM)Ulster Scientific, Inc.K772406AESTHESIOMETERFred Sammons, Inc.K771847TEMP-TESTERJablecki, Charles, Dr.K761133AESTHESIOMETERFred Sammons, 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.

↑