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FDA 510(k)

Z-WATCH SYSTEM

K-Number: K951727 · 1995-11-21

ApplicantPrizm Medical, Inc.
Decision Date1995-11-21
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

Z-WATCH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Prizm Medical, Inc.. It received FDA 510(k) clearance on 1995-11-21 under 510(k) number K951727. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the Z-WATCH SYSTEM?

Z-WATCH SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-21. The listed applicant is Prizm Medical, Inc.. The 510(k) number is K951727.

When did Z-WATCH SYSTEM receive FDA 510(k) clearance?

Z-WATCH SYSTEM received FDA 510(k) clearance on 1995-11-21, under 510(k) number K951727.

Who is the listed applicant for Z-WATCH SYSTEM?

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

What is the FDA product code for Z-WATCH SYSTEM?

The FDA product code for Z-WATCH SYSTEM is IPF.

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Other records listing Prizm Medical, 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.

K0331225000Z SYSTEM (OTC)K032239THERA-CREAM, MODEL TCT004K024181PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEMK012974PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007K944487ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODESK932299ELECTRO-MESH

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Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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