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FDA 510(k)

PATIENTCARE 1000

K-Number: K861324 · 1986-06-09

ApplicantCriticare Technologies Corp.
Decision Date1986-06-09
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENTCARE 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Criticare Technologies Corp.. It received FDA 510(k) clearance on 1986-06-09 under 510(k) number K861324. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENTCARE 1000?

PATIENTCARE 1000 is a medical device that received FDA 510(k) clearance on 1986-06-09. The listed applicant is Criticare Technologies Corp.. The 510(k) number is K861324.

When did PATIENTCARE 1000 receive FDA 510(k) clearance?

PATIENTCARE 1000 received FDA 510(k) clearance on 1986-06-09, under 510(k) number K861324.

Who is the listed applicant for PATIENTCARE 1000?

The FDA 510(k) record lists Criticare Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATIENTCARE 1000?

The FDA product code for PATIENTCARE 1000 is FRN.

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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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