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FDA 510(k)

ONGUARD 1000, CATALOG #043611-000 & 043611-001

K-Number: K870976 · 1987-05-06

ApplicantCobe Laboratories, Inc.
Decision Date1987-05-06
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ONGUARD 1000, CATALOG #043611-000 & 043611-001 is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1987-05-06 under 510(k) number K870976. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONGUARD 1000, CATALOG #043611-000 & 043611-001?

ONGUARD 1000, CATALOG #043611-000 & 043611-001 is a medical device that received FDA 510(k) clearance on 1987-05-06. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K870976.

When did ONGUARD 1000, CATALOG #043611-000 & 043611-001 receive FDA 510(k) clearance?

ONGUARD 1000, CATALOG #043611-000 & 043611-001 received FDA 510(k) clearance on 1987-05-06, under 510(k) number K870976.

Who is the listed applicant for ONGUARD 1000, CATALOG #043611-000 & 043611-001?

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

What is the FDA product code for ONGUARD 1000, CATALOG #043611-000 & 043611-001?

The FDA product code for ONGUARD 1000, CATALOG #043611-000 & 043611-001 is DTQ.

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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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