FDA 510(k)

EXTRAPURE REVERSE OSMOSIS WATER UNIT

K-Number: K822385 · 1982-10-13

ApplicantExtracorporeal Medical Specialities, Inc.

Decision Date1982-10-13

Product CodeFIP

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EXTRAPURE REVERSE OSMOSIS WATER UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1982-10-13 under 510(k) number K822385. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRAPURE REVERSE OSMOSIS WATER UNIT?

EXTRAPURE REVERSE OSMOSIS WATER UNIT is a medical device that received FDA 510(k) clearance on 1982-10-13. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K822385.

When did EXTRAPURE REVERSE OSMOSIS WATER UNIT receive FDA 510(k) clearance?

EXTRAPURE REVERSE OSMOSIS WATER UNIT received FDA 510(k) clearance on 1982-10-13, under 510(k) number K822385.

Who is the listed applicant for EXTRAPURE REVERSE OSMOSIS WATER UNIT?

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

What is the FDA product code for EXTRAPURE REVERSE OSMOSIS WATER UNIT?

The FDA product code for EXTRAPURE REVERSE OSMOSIS WATER UNIT is FIP.

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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.