Atlas FDA

OXY MONITOR 5-RANGE DUAL-THERMISTOR

FDA 510(k) clearance K832652 · decided 1983-12-22

Clearance details

K-number
K832652
Device name
OXY MONITOR 5-RANGE DUAL-THERMISTOR
Applicant
Litton Medical Electronics
Decision
Substantially Equivalent
Date received
1983-08-08
Decision date
1983-12-22
Days to decision
136 days
Clearance type
Traditional
Product code
KLK
Device class
2
Regulation number
868.2500
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Litton Medical Electronics

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MICROGAS 7650 TRANSCUTANEOUS MONITOR (K003943)Linde Medical Sensors AG2001-05-04
MICROGAS 7650 TRANSCUTANEOUS MONITOR (K991644)Linde Medical Sensors AG1999-05-21
SIEMENS SC9000/SC9015 TCP02/C02 MODULE (K980287)Siemens Medical Solutions USA, Inc.1998-08-12
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE (K924709)Air-Shields, Inc.1996-01-17
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR (K924679)Air-Shields Vickers, Inc.1995-02-21
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE (K925910)Hewlett-Packard Co.1993-07-29
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX (K893133)Mennen Medical, Inc.1989-07-14
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR (K870805)Novametrix Medical Systems, Inc.1987-05-27
515A NEO-TRAK NEONATAL MONITOR (K861861)Ge Medical Systems Information Technologies1986-07-10
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING (K860124)Mennen Medical, Inc.1986-05-09
KONTRON CUTANEOUS PO2 MONITOR 820 (K860951)Kontron Instruments, Inc.1986-04-09
PO-510 TCPO2 MONITOR (K852959)Sumitomo Electric Industries, Inc.1985-11-29

Recalls involving this device

No recalls on record reference this clearance.