SCHNEIDER-SHILEY PRESSURE MANOMETER— 510(k) K861605

Name: FDA 510(k) clearance K861605
Creator: U.S. Food and Drug Administration
Published: 1986-05-28

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K861605 for SCHNEIDER-SHILEY PRESSURE MANOMETER, Substantially Equivalent on 1986-05-28. Applicant: Shiley, Inc.. Device class: 2.

Clearance details

Applicant: Shiley, Inc.
Product code: Code KRK
Device class: Class 2
Regulation: 21 CFR 870.1140
Advisory panel: Cardiovascular
Date received: 1986-04-29
Decision date: 1986-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRK

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K950607 — UST-5268P-5 TRANSDUCER1995-09-15
K904674 — CENTRAL VENOUS PRESSURE MANOMETER1990-12-27
K884386 — ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK1989-01-05
K875322 — MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER1988-03-28
K830910 — MANOMETER SET C.V.P. #S 298/2991983-04-05

More clearances from Shiley, Inc.

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K911876 — SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR12001991-08-09
K910923 — BCD ADVANCED1991-04-09
K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS1991-01-14

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