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FDA 510(k)

LASER BACKPOINTER ASSEMBLY, MOD. 01-2487

K-Number: K800489 · 1980-03-25

ApplicantAtc Medical Technology, Inc.
Decision Date1980-03-25
Product CodeIWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 is the device name listed in this FDA 510(k) record. The listed applicant is Atc Medical Technology, Inc.. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K800489. 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 LASER BACKPOINTER ASSEMBLY, MOD. 01-2487?

LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Atc Medical Technology, Inc.. The 510(k) number is K800489.

When did LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 receive FDA 510(k) clearance?

LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800489.

Who is the listed applicant for LASER BACKPOINTER ASSEMBLY, MOD. 01-2487?

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

What is the FDA product code for LASER BACKPOINTER ASSEMBLY, MOD. 01-2487?

The FDA product code for LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 is IWE.

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Other records listing Atc Medical Technology, 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.

K982445MODULAP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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