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FDA 510(k)

EMERGENCY POWER PAC (EMPAC)

K-Number: K813273 · 1981-12-31

ApplicantOptical Micro Systems, Inc.
Decision Date1981-12-31
Product CodeHKP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EMERGENCY POWER PAC (EMPAC) is the device name listed in this FDA 510(k) record. The listed applicant is Optical Micro Systems, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813273. The device is classified under product code HKP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMERGENCY POWER PAC (EMPAC)?

EMERGENCY POWER PAC (EMPAC) is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Optical Micro Systems, Inc.. The 510(k) number is K813273.

When did EMERGENCY POWER PAC (EMPAC) receive FDA 510(k) clearance?

EMERGENCY POWER PAC (EMPAC) received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813273.

Who is the listed applicant for EMERGENCY POWER PAC (EMPAC)?

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

What is the FDA product code for EMERGENCY POWER PAC (EMPAC)?

The FDA product code for EMERGENCY POWER PAC (EMPAC) is HKP.

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Other records listing Optical Micro Systems, 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.

K950218OMS SLIMLINE PHACO HANDPIECEK946054DIPLOMAXK935223OPHTHALMIC SURGICAL SYSTEMK935226I/V POLEK935003ELECTRIC I/V POLE OR EIVP2K870068ASPIRATION REVERSAL CONTROL (ARC) MODULE

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Related Devices (Code: HKP)

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.

K952558AARON VAC 2Aaron Medical IndustriesK950056THE GRIESHABER AXIAL CUTTERGrieshaber & Co.K950287UNIVIT PROBEMedical Instrument Development Laboratories, Inc.K896622VISITEC VITRECTOMY UNITVisitec Co.K890595MENTOR ANTERIOR SEGMENT VITRECTORMentor O & O, Inc.K832074CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRACooperVision, 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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