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510(k) K893133

HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX by Mennen Medical, Inc. — Product Code KLK

K893133 is an FDA 510(k) premarket notification submitted by Mennen Medical, Inc. for the device "HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia), a Class II device regulated under 21 CFR 868.2500. Mennen Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1989
Date Received
April 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class
Class II
Regulation Number
868.2500
Review Panel
AN
Submission Type

Other clearances by Mennen Medical, Inc.

  • K141441 — MENNTOR X7 (January 9, 2015)
  • K131789 — CEREBRALOGIK- AEEG (December 27, 2013)
  • K123792 — HORIZON XVU (FFR) (August 30, 2013)
  • K093766 — VITALOGIK 6000/6500 (May 7, 2010)
  • K091165 — HORIZON XVU (August 7, 2009)
  • K083063 — BIS INTERFACE FOR VITALOGIK PATIENT MONITORS (December 16, 2008)
  • K081484 — HORIZON XVU (June 20, 2008)
  • K073140 — VITALOGIK MODEL 4000/4500 (November 21, 2007)
  • K071899 — BIS MODULE FOR ENVOY PATIENT MONITOR (October 22, 2007)
  • K071348 — EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM (September 7, 2007)

Other clearances for product code KLK

  • K003943 — MICROGAS 7650 TRANSCUTANEOUS MONITOR (May 4, 2001)
  • K991644 — MICROGAS 7650 TRANSCUTANEOUS MONITOR (May 21, 1999)
  • K980287 — SIEMENS SC9000/SC9015 TCP02/C02 MODULE (August 12, 1998)
  • K924709 — SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE (January 17, 1996)
  • K924679 — OXYCARE(TM) OXYGEN CONTROLLER/MONITOR (February 21, 1995)
  • K925910 — HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE (July 29, 1993)
  • K870805 — MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR (May 27, 1987)
  • K861861 — 515A NEO-TRAK NEONATAL MONITOR (July 10, 1986)
  • K860124 — HORIZON 2000 TRANSCUTANEOUS GAS MONITORING (May 9, 1986)
  • K860951 — KONTRON CUTANEOUS PO2 MONITOR 820 (April 9, 1986)

FDA data resources