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FDA 510(k)

THERMAFLEX, MODEL SD 55 C.P.M.H.

K-Number: K945803 · 1995-05-11

ApplicantBurke Neutech, Inc.
Decision Date1995-05-11
Product CodeJFA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMAFLEX, MODEL SD 55 C.P.M.H. is the device name listed in this FDA 510(k) record. The listed applicant is Burke Neutech, Inc.. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K945803. 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 THERMAFLEX, MODEL SD 55 C.P.M.H.?

THERMAFLEX, MODEL SD 55 C.P.M.H. is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Burke Neutech, Inc.. The 510(k) number is K945803.

When did THERMAFLEX, MODEL SD 55 C.P.M.H. receive FDA 510(k) clearance?

THERMAFLEX, MODEL SD 55 C.P.M.H. received FDA 510(k) clearance on 1995-05-11, under 510(k) number K945803.

Who is the listed applicant for THERMAFLEX, MODEL SD 55 C.P.M.H.?

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

What is the FDA product code for THERMAFLEX, MODEL SD 55 C.P.M.H.?

The FDA product code for THERMAFLEX, MODEL SD 55 C.P.M.H. is JFA.

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Other records listing Burke Neutech, 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.

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.K900581DANNIFLEX CPM 880(TM)Buckman Co., Inc.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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