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FDA 510(k)

REGENESIS MODEL 42

K-Number: K972093 · 1997-10-21

ApplicantRegenesis Biomedical, Inc.
Decision Date1997-10-21
Product CodeILX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REGENESIS MODEL 42 is the device name listed in this FDA 510(k) record. The listed applicant is Regenesis Biomedical, Inc.. It received FDA 510(k) clearance on 1997-10-21 under 510(k) number K972093. The device is classified under product code ILX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGENESIS MODEL 42?

REGENESIS MODEL 42 is a medical device that received FDA 510(k) clearance on 1997-10-21. The listed applicant is Regenesis Biomedical, Inc.. The 510(k) number is K972093.

When did REGENESIS MODEL 42 receive FDA 510(k) clearance?

REGENESIS MODEL 42 received FDA 510(k) clearance on 1997-10-21, under 510(k) number K972093.

Who is the listed applicant for REGENESIS MODEL 42?

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

What is the FDA product code for REGENESIS MODEL 42?

The FDA product code for REGENESIS MODEL 42 is ILX.

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Other records listing Regenesis Biomedical, 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.

K223620Reprieve by RegenesisTMK131979PROVANT THERAPY SYSTEMK091791PROVANT SYSTEM, MODEL 4201

Related Devices (Code: ILX)

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.

K241395Active System; Avenue8Caerus CorporationK202337Pulsed electromagnetic field wrapHi-Dow International, Inc.K190251RecoveryRxBioelectronics CorporationK131979PROVANT THERAPY SYSTEMRegenesis Biomedical, Inc.K121702ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICEOrthocor MedicalK121338ZEOBIIvivi Health Science, LLC

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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