OXYMETER— 510(k) K800631

Substantially Equivalent

Dragerwerk AG

FDA 510(k) clearance K800631 for OXYMETER, Substantially Equivalent on 1980-04-02. Applicant: Dragerwerk AG. Device class: 2.

Clearance details

Applicant: Dragerwerk AG
Product code: Code KLK
Device class: Class 2
Regulation: 21 CFR 868.2500
Advisory panel: Anesthesiology
Date received: 1980-03-20
Decision date: 1980-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLK

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 Dragerwerk AG

K913394 — INCUBATOR 8000 IC1991-11-22
K900752 — INCUBATOR 80001990-08-02

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