TRANSCUTANEOUS OXYGEN PERFUSION MONITOR— 510(k) K780458

Name: FDA 510(k) clearance K780458
Creator: U.S. Food and Drug Administration
Published: 1978-10-10

Substantially Equivalent

Narco Air-Shields

FDA 510(k) clearance K780458 for TRANSCUTANEOUS OXYGEN PERFUSION MONITOR, Substantially Equivalent on 1978-10-10. Applicant: Narco Air-Shields. Device class: 2.

Clearance details

Applicant: Narco Air-Shields
Product code: Code KLK
Device class: Class 2
Regulation: 21 CFR 868.2500
Advisory panel: Anesthesiology
Date received: 1978-03-23
Decision date: 1978-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLK

view all

K003943 — MICROGAS 7650 TRANSCUTANEOUS MONITOR2001-05-04
K991644 — MICROGAS 7650 TRANSCUTANEOUS MONITOR1999-05-21
K980287 — SIEMENS SC9000/SC9015 TCP02/C02 MODULE1998-08-12
K924709 — SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE1996-01-17
K924679 — OXYCARE(TM) OXYGEN CONTROLLER/MONITOR1995-02-21

More clearances from Narco Air-Shields

view all

K820114 — SYSTEM V.HEART RATE/RESPIR. RATE MONIT.1982-02-12
K810953 — MODEL 533 PHOTOTHERAPY UNIT1981-04-23
K810474 — PROBE COVER1981-03-31
K802800 — NARCO AIR-SHEILDS SYS. 100 MONITOR SYS1980-11-24
K802126 — ISOLETTE INCUBATOR C-1001980-09-26

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