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FDA 510(k)

PERIFORM

K-Number: K981277 · 1998-11-20

ApplicantVerimed Holdings, Inc.
Decision Date1998-11-20
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PERIFORM is the device name listed in this FDA 510(k) record. The listed applicant is Verimed Holdings, Inc.. It received FDA 510(k) clearance on 1998-11-20 under 510(k) number K981277. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIFORM?

PERIFORM is a medical device that received FDA 510(k) clearance on 1998-11-20. The listed applicant is Verimed Holdings, Inc.. The 510(k) number is K981277.

When did PERIFORM receive FDA 510(k) clearance?

PERIFORM received FDA 510(k) clearance on 1998-11-20, under 510(k) number K981277.

Who is the listed applicant for PERIFORM?

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

What is the FDA product code for PERIFORM?

The FDA product code for PERIFORM is HIR.

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Other records listing Verimed Holdings, 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.

K954127BIOFEEDBACK DEVICEK951969MYOEXORCISER II FUALK930670PHYACTION 787K922550ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)K913912VERIMED PERINEOMETERK893220VERIMED MYOEXORCISER VERISTIM

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Related Devices (Code: HIR)

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.

K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 Innovations

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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