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FDA 510(k)

WALLACH DIGITAL IMAGING SYSTEM

K-Number: K950630 · 1995-11-22

ApplicantWallach Surgical Devices, Inc.
Decision Date1995-11-22
Product CodeLMB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WALLACH DIGITAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wallach Surgical Devices, Inc.. It received FDA 510(k) clearance on 1995-11-22 under 510(k) number K950630. The device is classified under product code LMB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLACH DIGITAL IMAGING SYSTEM?

WALLACH DIGITAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-22. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K950630.

When did WALLACH DIGITAL IMAGING SYSTEM receive FDA 510(k) clearance?

WALLACH DIGITAL IMAGING SYSTEM received FDA 510(k) clearance on 1995-11-22, under 510(k) number K950630.

Who is the listed applicant for WALLACH DIGITAL IMAGING SYSTEM?

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

What is the FDA product code for WALLACH DIGITAL IMAGING SYSTEM?

The FDA product code for WALLACH DIGITAL IMAGING SYSTEM is LMB.

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Other records listing Wallach Surgical Devices, 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.

K021224ENDOCERVICAL BLOCK NEEDLEK020711WALLACH LOOP ELECTRODEK000768WALLACH QUANTUM 500 ELECTROSURGICAL GENERATORK992736WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUMK991669PMS 750 FINGERSWITCHK983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)

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Related Devices (Code: LMB)

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.

K992131SAMSUNG RAYPAX LONG TERM ARCHIVESamsung Sds Co., Ltd.K984405ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp.K983447WISE (II) IMAGE MANAGEMENT SYSTEMSectra-Imtec ABK980243PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)Parameter Developments, Inc.K973463OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVEO Tech, Inc.K973413ID. STORE (RELEASE 2.0)I.S.G. Technologies, Inc.

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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