TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS— 510(k) K830197

Name: FDA 510(k) clearance K830197
Creator: U.S. Food and Drug Administration
Published: 1983-11-29

Substantially Equivalent

Diamond Shamrock Corp.

FDA 510(k) clearance K830197 for TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS, Substantially Equivalent on 1983-11-29. Applicant: Diamond Shamrock Corp.. Device class: 2.

Clearance details

Applicant: Diamond Shamrock Corp.
Product code: Code KLK
Device class: Class 2
Regulation: 21 CFR 868.2500
Advisory panel: Anesthesiology
Date received: 1983-01-20
Decision date: 1983-11-29
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 Diamond Shamrock Corp.

view all

K760262 — RADIOASSY KIT, 3H-FOLATE1976-08-03

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