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FDA 510(k)

UROGRAM CYSTOMETROGRAM

K-Number: K936041 · 1994-04-18

ApplicantMyo/Kinetic Systems, Inc.
Decision Date1994-04-18
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROGRAM CYSTOMETROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Myo/Kinetic Systems, Inc.. It received FDA 510(k) clearance on 1994-04-18 under 510(k) number K936041. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROGRAM CYSTOMETROGRAM?

UROGRAM CYSTOMETROGRAM is a medical device that received FDA 510(k) clearance on 1994-04-18. The listed applicant is Myo/Kinetic Systems, Inc.. The 510(k) number is K936041.

When did UROGRAM CYSTOMETROGRAM receive FDA 510(k) clearance?

UROGRAM CYSTOMETROGRAM received FDA 510(k) clearance on 1994-04-18, under 510(k) number K936041.

Who is the listed applicant for UROGRAM CYSTOMETROGRAM?

The FDA 510(k) record lists Myo/Kinetic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROGRAM CYSTOMETROGRAM?

The FDA product code for UROGRAM CYSTOMETROGRAM is FEN.

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Other records listing Myo/Kinetic Systems, 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.

K945937TE-800 PELVIC FLOOR EXERCISERK945292TS-700P CONTROL XP ELECTRICAL STIMULATORK944972URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRYK932611NEUROMUSCULAR STIMULATORK932764THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)K932399THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)

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Related Devices (Code: FEN)

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.

K212830CT3000ProSrs MedicalK082701URONIRS, MODEL 2000Urodynamix Technologies, Ltd.K073552LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORYLaborie Medical Technologies, Corp.K001386ACCUSET SENSOR, MODEL 2000Pelvicare, Inc.K992715NEURO URODYNAMIC SUITE, MODEL 9032E0101Medtronic Functional Diagnostics A/SK983325IN-PROBE II URODYNAMIC SYSTEMInfluence, 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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