Atlas FDA

TRANSCUTANEOUS 800-OXYGEN MONITORS/801

FDA 510(k) clearance K840993 · decided 1984-04-24

Clearance details

K-number
K840993
Device name
TRANSCUTANEOUS 800-OXYGEN MONITORS/801
Applicant
Novametrix Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
1984-03-08
Decision date
1984-04-24
Days to decision
47 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

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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.

PMA approvals by this applicant

RecordFirmDate
TCO2M MODEL 818 MONITOR (P810022/S014)Novametrix Medical Systems, Inc.1987-10-09
TCO2M MODEL 818 MONITOR (P810022/S013)Novametrix Medical Systems, Inc.1987-01-29
TCO2M MODEL 818 MONITOR (P810022/S012)Novametrix Medical Systems, Inc.1986-06-05
TCO2M MODEL 818 MONITOR (P810022/S011)Novametrix Medical Systems, Inc.1985-11-21
TCO2M MODEL 818 MONITOR (P810022/S009)Novametrix Medical Systems, Inc.1985-09-03
TCO2M MODEL 818 MONITOR (P810022/S010)Novametrix Medical Systems, Inc.1985-07-01
TCO2M MODEL 818 MONITOR (P810022/S008)Novametrix Medical Systems, Inc.1985-03-11
TCO2M MODEL 818 MONITOR (P810022/S007)Novametrix Medical Systems, Inc.1984-12-04