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FDA 510(k)

DANNIFLEX CPM 880(TM)

K-Number: K900581 · 1990-02-20

ApplicantBuckman Co., Inc.
Decision Date1990-02-20
Product CodeJFA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DANNIFLEX CPM 880(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1990-02-20 under 510(k) number K900581. The device is classified under product code JFA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANNIFLEX CPM 880(TM)?

DANNIFLEX CPM 880(TM) is a medical device that received FDA 510(k) clearance on 1990-02-20. The listed applicant is Buckman Co., Inc.. The 510(k) number is K900581.

When did DANNIFLEX CPM 880(TM) receive FDA 510(k) clearance?

DANNIFLEX CPM 880(TM) received FDA 510(k) clearance on 1990-02-20, under 510(k) number K900581.

Who is the listed applicant for DANNIFLEX CPM 880(TM)?

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

What is the FDA product code for DANNIFLEX CPM 880(TM)?

The FDA product code for DANNIFLEX CPM 880(TM) is JFA.

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Other records listing Buckman Co., Inc. as applicant

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Related Devices (Code: JFA)

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.

K945803THERMAFLEX, MODEL SD 55 C.P.M.H.Burke Neutech, Inc.K931016JACE MODEL H440 HAND CPM DEVICEJace Systems, Inc.K933418HAND THERAPY ASSOSTBardon Ent., Inc.K921351JACE MODEL PM-410 HAND CPM DEVICEJace Systems, Inc.K900794MOBILIMB H3 HAND CPM UNITToronto Medical Corp.K880686TORONTO/MOBILIMB HAND C.P.M.Toronto Medical Corp.

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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