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)

A2J MZ 45 LASER LIGHT FOR POSITIONING

K-Number: K881591 · 1988-04-27

ApplicantA2j, Inc.
Decision Date1988-04-27
Product CodeIWX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

A2J MZ 45 LASER LIGHT FOR POSITIONING is the device name listed in this FDA 510(k) record. The listed applicant is A2j, Inc.. It received FDA 510(k) clearance on 1988-04-27 under 510(k) number K881591. The device is classified under product code IWX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A2J MZ 45 LASER LIGHT FOR POSITIONING?

A2J MZ 45 LASER LIGHT FOR POSITIONING is a medical device that received FDA 510(k) clearance on 1988-04-27. The listed applicant is A2j, Inc.. The 510(k) number is K881591.

When did A2J MZ 45 LASER LIGHT FOR POSITIONING receive FDA 510(k) clearance?

A2J MZ 45 LASER LIGHT FOR POSITIONING received FDA 510(k) clearance on 1988-04-27, under 510(k) number K881591.

Who is the listed applicant for A2J MZ 45 LASER LIGHT FOR POSITIONING?

The FDA 510(k) record lists A2j, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A2J MZ 45 LASER LIGHT FOR POSITIONING?

The FDA product code for A2J MZ 45 LASER LIGHT FOR POSITIONING is IWX.

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

Other records listing A2j, 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.

K931974AZ 92K904127A2J TELEMETERK880981A2J MZ 44 B TYPE

Related Devices (Code: IWX)

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.

K850813MOBILE LEAD PLASTIC X-RAY BARRIERSVictoreen, Inc.K781068AUTOMATIC FILM PROCESSORIO M. R80Tecnomed, 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.

↑