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FDA 510(k)

ARROW HANDS-OFF THERMO-PACE

K-Number: K895268 · 1989-11-06

ApplicantArrow Intl., Inc.
Decision Date1989-11-06
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARROW HANDS-OFF THERMO-PACE is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1989-11-06 under 510(k) number K895268. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARROW HANDS-OFF THERMO-PACE?

ARROW HANDS-OFF THERMO-PACE is a medical device that received FDA 510(k) clearance on 1989-11-06. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K895268.

When did ARROW HANDS-OFF THERMO-PACE receive FDA 510(k) clearance?

ARROW HANDS-OFF THERMO-PACE received FDA 510(k) clearance on 1989-11-06, under 510(k) number K895268.

Who is the listed applicant for ARROW HANDS-OFF THERMO-PACE?

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

What is the FDA product code for ARROW HANDS-OFF THERMO-PACE?

The FDA product code for ARROW HANDS-OFF THERMO-PACE is DQO.

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Related Devices (Code: DQO)

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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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