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FDA 510(k)

BIOSEARCH ANAL BIOFEEDBACK DEVICE

K-Number: K902843 · 1990-09-14

ApplicantBiosearch Medical Products, Inc.
Decision Date1990-09-14
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOSEARCH ANAL BIOFEEDBACK DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Biosearch Medical Products, Inc.. It received FDA 510(k) clearance on 1990-09-14 under 510(k) number K902843. The device is classified under product code FAP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSEARCH ANAL BIOFEEDBACK DEVICE?

BIOSEARCH ANAL BIOFEEDBACK DEVICE is a medical device that received FDA 510(k) clearance on 1990-09-14. The listed applicant is Biosearch Medical Products, Inc.. The 510(k) number is K902843.

When did BIOSEARCH ANAL BIOFEEDBACK DEVICE receive FDA 510(k) clearance?

BIOSEARCH ANAL BIOFEEDBACK DEVICE received FDA 510(k) clearance on 1990-09-14, under 510(k) number K902843.

Who is the listed applicant for BIOSEARCH ANAL BIOFEEDBACK DEVICE?

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

What is the FDA product code for BIOSEARCH ANAL BIOFEEDBACK DEVICE?

The FDA product code for BIOSEARCH ANAL BIOFEEDBACK DEVICE is FAP.

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Other records listing Biosearch Medical Products, 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.

K051480ENTERAL FEEDING TUBEK970145PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)K964871BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTSK951260URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANTK944614MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEMK932295NON-BALLOON REPLACEMENT GASTROSTOMY KIT

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Related Devices (Code: FAP)

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.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., Inc.

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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