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FDA 510(k)

A2J TELEMETER

K-Number: K904127 · 1991-01-04

ApplicantA2j, Inc.
Decision Date1991-01-04
Product CodeIWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

A2J TELEMETER is the device name listed in this FDA 510(k) record. The listed applicant is A2j, Inc.. It received FDA 510(k) clearance on 1991-01-04 under 510(k) number K904127. The device is classified under product code IWE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A2J TELEMETER?

A2J TELEMETER is a medical device that received FDA 510(k) clearance on 1991-01-04. The listed applicant is A2j, Inc.. The 510(k) number is K904127.

When did A2J TELEMETER receive FDA 510(k) clearance?

A2J TELEMETER received FDA 510(k) clearance on 1991-01-04, under 510(k) number K904127.

Who is the listed applicant for A2J TELEMETER?

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 TELEMETER?

The FDA product code for A2J TELEMETER is IWE.

Related Clinical Trials

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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 92K881591A2J MZ 45 LASER LIGHT FOR POSITIONINGK880981A2J MZ 44 B TYPE

Related Devices (Code: IWE)

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.

K973162DUAL RADIATION TARGETING SYSTEM DRTS DRAPEHogan & HartsonK955236GREEN TEC-2100Medtec, Inc.K954414CENTRALITE BACKPOINTERDiacor, Inc.K950293TEC-2110 GREEN LASER MODEL MT-HNGMedtec, Inc.K950112CENTRALITE(R)-DLL SERIESDiacor, Inc.K951601MED-TEC STRING RETICLE TRAYMedtec, 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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