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FDA 510(k)

PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)

K-Number: K853812 · 1985-11-01

ApplicantBiosan Laboratories, Inc.
Decision Date1985-11-01
Product CodeHLX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Biosan Laboratories, Inc.. It received FDA 510(k) clearance on 1985-11-01 under 510(k) number K853812. The device is classified under product code HLX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)?

PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Biosan Laboratories, Inc.. The 510(k) number is K853812.

When did PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) receive FDA 510(k) clearance?

PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) received FDA 510(k) clearance on 1985-11-01, under 510(k) number K853812.

Who is the listed applicant for PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)?

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

What is the FDA product code for PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)?

The FDA product code for PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) is HLX.

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 Biosan Laboratories, 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.

K860642PHOTRON VISUAL FIELD ANALYZERK832763TOBRAMYCIN REAGENTK833193RADIOIMMUNOASSAY, THYROID STIMU. HORMONEK834023BIO-SCIENCE LABORATORIES T4 REAGENTK833318NORMAL GOAT SERUMK833191ABNORMAL URINE CONTROL

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Related Devices (Code: HLX)

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.

K003442MODIFICATION TO EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.K983983EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.K925741CLARUS ENDOSCOPIC HOOK KNIFEClarus Medical Systems, Inc.K914393RETINA TESTERRetina TesterK914163SCOPTOPIC SENSITIVITY TEST-1[SST-1]Lkc Technologies, Inc.K873990IRAS EDS INTERFEROMETRIC STIMULATORRandwal Instrument Co., 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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