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FDA 510(k)

PEAK FLOW RATE METER

K-Number: K893827 · 1989-08-11

ApplicantLaytech Medical Co.
Decision Date1989-08-11
Product CodeFFG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PEAK FLOW RATE METER is the device name listed in this FDA 510(k) record. The listed applicant is Laytech Medical Co.. It received FDA 510(k) clearance on 1989-08-11 under 510(k) number K893827. The device is classified under product code FFG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEAK FLOW RATE METER?

PEAK FLOW RATE METER is a medical device that received FDA 510(k) clearance on 1989-08-11. The listed applicant is Laytech Medical Co.. The 510(k) number is K893827.

When did PEAK FLOW RATE METER receive FDA 510(k) clearance?

PEAK FLOW RATE METER received FDA 510(k) clearance on 1989-08-11, under 510(k) number K893827.

Who is the listed applicant for PEAK FLOW RATE METER?

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

What is the FDA product code for PEAK FLOW RATE METER?

The FDA product code for PEAK FLOW RATE METER is FFG.

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 Laytech Medical Co. 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.

K896581PEDIATRIC DRAIN BAG

Related Devices (Code: FFG)

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.

K883274SURGITEK (R) UROFLOW SYSTEMMedical Engineering Corp.K850169ERIS URO-DIAGNOSTIC SYSTEMEris Medical TechnologyK8443381URO-LOG HOME DIAGNOSTIC PACKEpcom Medical Systems, Inc.K843441URINARY DRAINAGE CONTAINER 2012-WITHVital Metrics, Inc.K843442URINARY DRAINAGE CONTAINER 2013 WITHVital Metrics, Inc.K844030ACCUMETER ELECTRONIC URINEMETER SYSTEMTravenol Laboratories, S.A.

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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