FDA 510(k)

KEATES I/A SYSTEM FRIGITRONICS 4000

K-Number: K822599 · 1982-10-06

ApplicantFrigitronics of Connecticut, Inc.

Decision Date1982-10-06

Product CodeHKP

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

KEATES I/A SYSTEM FRIGITRONICS 4000 is the device name listed in this FDA 510(k) record. The listed applicant is Frigitronics of Connecticut, Inc.. It received FDA 510(k) clearance on 1982-10-06 under 510(k) number K822599. 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 KEATES I/A SYSTEM FRIGITRONICS 4000?

KEATES I/A SYSTEM FRIGITRONICS 4000 is a medical device that received FDA 510(k) clearance on 1982-10-06. The listed applicant is Frigitronics of Connecticut, Inc.. The 510(k) number is K822599.

When did KEATES I/A SYSTEM FRIGITRONICS 4000 receive FDA 510(k) clearance?

KEATES I/A SYSTEM FRIGITRONICS 4000 received FDA 510(k) clearance on 1982-10-06, under 510(k) number K822599.

Who is the listed applicant for KEATES I/A SYSTEM FRIGITRONICS 4000?

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

What is the FDA product code for KEATES I/A SYSTEM FRIGITRONICS 4000?

The FDA product code for KEATES I/A SYSTEM FRIGITRONICS 4000 is HKP.

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Other records listing Frigitronics of Connecticut, Inc. as applicant

K891282MIC-100 WITH CRYOPROBES K872362FRIGITRONICS ACC-1000 CAPSULE CUTTER K853308KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 K834577I/A PROBE LINES K840536CRYO SURG 5900 K834437KEATES IRRIGATION/ASPIRATION/VITREOUS

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Related Devices (Code: HKP)

K952558AARON VAC 2Aaron Medical Industries K950056THE 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.