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FDA 510(k)

NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS

K-Number: K860472 · 1986-07-03

ApplicantNuclear Diagnostics, Inc.
Decision Date1986-07-03
Product CodeIWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-07-03 under 510(k) number K860472. 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 NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS?

NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS is a medical device that received FDA 510(k) clearance on 1986-07-03. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K860472.

When did NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS receive FDA 510(k) clearance?

NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS received FDA 510(k) clearance on 1986-07-03, under 510(k) number K860472.

Who is the listed applicant for NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS?

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

What is the FDA product code for NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS?

The FDA product code for NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS is IWE.

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Other records listing Nuclear Diagnostics, 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.

K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYK932406NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KITK872177TIPSEP-CORTISOL RIA DIAGNOSTIC KITK862312ENZLIPASE, ENZYMATIC LIPASE KITK861735TIPSEP-TBG ASSAYK852291TIPSEP DIGOXIN RIA

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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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