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FDA 510(k)

CAMSYS 6300

K-Number: K920574 · 1993-02-17

ApplicantF.M. Wiest USA, Inc.
Decision Date1993-02-17
Product CodeEXQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CAMSYS 6300 is the device name listed in this FDA 510(k) record. The listed applicant is F.M. Wiest USA, Inc.. It received FDA 510(k) clearance on 1993-02-17 under 510(k) number K920574. The device is classified under product code EXQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAMSYS 6300?

CAMSYS 6300 is a medical device that received FDA 510(k) clearance on 1993-02-17. The listed applicant is F.M. Wiest USA, Inc.. The 510(k) number is K920574.

When did CAMSYS 6300 receive FDA 510(k) clearance?

CAMSYS 6300 received FDA 510(k) clearance on 1993-02-17, under 510(k) number K920574.

Who is the listed applicant for CAMSYS 6300?

The FDA 510(k) record lists F.M. Wiest USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAMSYS 6300?

The FDA product code for CAMSYS 6300 is EXQ.

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Other records listing F.M. Wiest USA, 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.

K921871HYSTEROMAT(TM) 3700K920575MERKUR 4000K915751URETEROMAT 4400K911844HYSTEROFLATOR 1500K912071SPACE(TM) 7500K910883LAPAROFLATOR ELECTRONIC 3509

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Related Devices (Code: EXQ)

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.

K253537Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)Bright Uro, Inc.K243052Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))Bright Uro, Inc.K931282VOLUME TRANSDUCERLife-Tech Intl., Inc.K931574ADVANCE MODEL UDS-ADVLaborie Medical Technologies, Ltd.K880391DACOMED CYSTOMETERDacomed Corp.K812177LIFE-TECH #1857 PRESSURE/POLOT MODULELife-Tech Instruments, 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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