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FDA 510(k)

DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000

K-Number: K944885 · 1995-02-14

ApplicantKolvin Industries , Ltd.
Decision Date1995-02-14
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Kolvin Industries , Ltd.. It received FDA 510(k) clearance on 1995-02-14 under 510(k) number K944885. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000?

DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000 is a medical device that received FDA 510(k) clearance on 1995-02-14. The listed applicant is Kolvin Industries , Ltd.. The 510(k) number is K944885.

When did DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000 receive FDA 510(k) clearance?

DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000 received FDA 510(k) clearance on 1995-02-14, under 510(k) number K944885.

Who is the listed applicant for DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000?

The FDA 510(k) record lists Kolvin Industries , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000?

The FDA product code for DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000 is ISA.

Other records listing Kolvin Industries , Ltd. 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.

K944884DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B

Related Devices (Code: ISA)

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.

K243488VMAT PROTermosaludK240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K210166Omnispec ED1000Medispec, Ltd.K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave TrtK220538DolorClast RadialE.M.S Electro Medical Systems S.A

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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