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FDA 510(k)

P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS)

K-Number: K915405 · 1992-02-04

ApplicantPrecise Optics Photo Medic Equipment, Inc.
Decision Date1992-02-04
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS) is the device name listed in this FDA 510(k) record. The listed applicant is Precise Optics Photo Medic Equipment, Inc.. It received FDA 510(k) clearance on 1992-02-04 under 510(k) number K915405. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS)?

P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS) is a medical device that received FDA 510(k) clearance on 1992-02-04. The listed applicant is Precise Optics Photo Medic Equipment, Inc.. The 510(k) number is K915405.

When did P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS) receive FDA 510(k) clearance?

P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS) received FDA 510(k) clearance on 1992-02-04, under 510(k) number K915405.

Who is the listed applicant for P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS)?

The FDA 510(k) record lists Precise Optics Photo Medic Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS)?

The FDA product code for P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS) is JAA.

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.

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Other records listing Precise Optics Photo Medic Equipment, 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.

K921516P2900 X-RAY GENERATOR

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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