URINE METER— 510(k) K935578

Substantially Equivalent

Puritas Health Care, Inc.

FDA 510(k) clearance K935578 for URINE METER, Substantially Equivalent on 1993-12-17. Applicant: Puritas Health Care, Inc.. Device class: 2.

Clearance details

Applicant: Puritas Health Care, Inc.
Product code: Code EXR
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 1993-11-18
Decision date: 1993-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Milford, CT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Puritas Health Care, Inc.

K942339 — SKIN NEUVEAU SCAR TREATMENT1994-11-28
K941197 — SILK*SKIN SCAR TREATMENT1994-08-11
K935600 — TRACHEAL SUCTION CATHETER1994-05-10
K935531 — OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP1994-05-05
K940074 — Y-TYPE BLOOD ADMINISTRATION SET1994-04-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.