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FDA 510(k)

SUTTER MODEL 6000 HAND CPM DEVICE

K-Number: K945221 · 1995-02-27

ApplicantSutter Corp.
Decision Date1995-02-27
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUTTER MODEL 6000 HAND CPM DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Corp.. It received FDA 510(k) clearance on 1995-02-27 under 510(k) number K945221. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTTER MODEL 6000 HAND CPM DEVICE?

SUTTER MODEL 6000 HAND CPM DEVICE is a medical device that received FDA 510(k) clearance on 1995-02-27. The listed applicant is Sutter Corp.. The 510(k) number is K945221.

When did SUTTER MODEL 6000 HAND CPM DEVICE receive FDA 510(k) clearance?

SUTTER MODEL 6000 HAND CPM DEVICE received FDA 510(k) clearance on 1995-02-27, under 510(k) number K945221.

Who is the listed applicant for SUTTER MODEL 6000 HAND CPM DEVICE?

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

What is the FDA product code for SUTTER MODEL 6000 HAND CPM DEVICE?

The FDA product code for SUTTER MODEL 6000 HAND CPM DEVICE is BXB.

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Other records listing Sutter Corp. as applicant

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.

K943354SUTTER HAMMERTOE JOINT PROSTHESISK931588SUTTER PROXIMAL INTERPHALANGEAL JOINTK924654FIRST METATARSOPHALANGEAL JOINT MOTION SPLINTK914860SUTTER MODEL 10000 LEG CPM DEVICEK902707MODEL 9000 AT ANKLE CPM DEVICEK890607SUTTER HOSPITAL CPM

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Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.

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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