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FDA 510(k)

FLOWMATE HAND PUMP

K-Number: K915459 · 1994-02-15

ApplicantPsi Medical Products, Inc.
Decision Date1994-02-15
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLOWMATE HAND PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Psi Medical Products, Inc.. It received FDA 510(k) clearance on 1994-02-15 under 510(k) number K915459. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOWMATE HAND PUMP?

FLOWMATE HAND PUMP is a medical device that received FDA 510(k) clearance on 1994-02-15. The listed applicant is Psi Medical Products, Inc.. The 510(k) number is K915459.

When did FLOWMATE HAND PUMP receive FDA 510(k) clearance?

FLOWMATE HAND PUMP received FDA 510(k) clearance on 1994-02-15, under 510(k) number K915459.

Who is the listed applicant for FLOWMATE HAND PUMP?

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

What is the FDA product code for FLOWMATE HAND PUMP?

The FDA product code for FLOWMATE HAND PUMP is KOD.

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Other records listing Psi Medical Products, 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.

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Related Devices (Code: KOD)

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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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