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FDA 510(k)

PERITONE

K-Number: K800191 · 1980-04-16

ApplicantLaurie Ann Kaiser, Ph.D.
Decision Date1980-04-16
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PERITONE is the device name listed in this FDA 510(k) record. The listed applicant is Laurie Ann Kaiser, Ph.D.. It received FDA 510(k) clearance on 1980-04-16 under 510(k) number K800191. 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 PERITONE?

PERITONE is a medical device that received FDA 510(k) clearance on 1980-04-16. The listed applicant is Laurie Ann Kaiser, Ph.D.. The 510(k) number is K800191.

When did PERITONE receive FDA 510(k) clearance?

PERITONE received FDA 510(k) clearance on 1980-04-16, under 510(k) number K800191.

Who is the listed applicant for PERITONE?

The FDA 510(k) record lists Laurie Ann Kaiser, Ph.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERITONE?

The FDA product code for PERITONE is HIR.

Related Clinical Trials

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.

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Other records listing Laurie Ann Kaiser, Ph.D. 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.

K860552PERITONE DISPOSAL SHEATH - RUBBER AND VINYL

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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