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FDA 510(k)

ORTHO TECH CRYOLOGIC SYSTEM

K-Number: K940429 · 1994-07-12

ApplicantOrthopedic Technology, Inc.
Decision Date1994-07-12
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

ORTHO TECH CRYOLOGIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Technology, Inc.. It received FDA 510(k) clearance on 1994-07-12 under 510(k) number K940429. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ORTHO TECH CRYOLOGIC SYSTEM?

ORTHO TECH CRYOLOGIC SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Orthopedic Technology, Inc.. The 510(k) number is K940429.

When did ORTHO TECH CRYOLOGIC SYSTEM receive FDA 510(k) clearance?

ORTHO TECH CRYOLOGIC SYSTEM received FDA 510(k) clearance on 1994-07-12, under 510(k) number K940429.

Who is the listed applicant for ORTHO TECH CRYOLOGIC SYSTEM?

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

What is the FDA product code for ORTHO TECH CRYOLOGIC SYSTEM?

The FDA product code for ORTHO TECH CRYOLOGIC SYSTEM is ILO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Orthopedic Technology, Inc. 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.

K843780VENT-A-CAST

Related Devices (Code: ILO)

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.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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