Home / 510(k) Clearances / K834460

510(k) K834460

MODEL 1888 ALPHA COS/RESPIRATION CAR by Spacelabs, Inc. — Product Code LLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1984
Date Received
December 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Legging, Compression, Non-Inflatable
Device Class
Class II
Regulation Number
880.5780
Review Panel
HO
Submission Type

Other clearances by Spacelabs, Inc.

  • K954962 — SPACELABS MEDICAL MULTIGAS ANALYZER (May 31, 1996)
  • K951605 — SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM (July 14, 1995)
  • K950779 — HEART RATE VARIABILITY SOFTWARE OPTION (April 25, 1995)
  • K941165 — COMET CAPNOGRAPH MODULE (October 6, 1994)
  • K923788 — SPACE LABS MODEL 90560 (December 6, 1993)
  • K912742 — ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE (April 20, 1992)
  • K913038 — SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION (October 4, 1991)
  • K905065 — DEFIBRILLATOR LEAD ADAPTER (April 12, 1991)
  • K910029 — PATIENT CARE MANAGEMENT SYSTEM MODIFICATION (January 31, 1991)
  • K896903 — FIRST MEDIC MODEL 510 (December 27, 1990)

Other clearances for product code LLK

  • K903532 — UNNA-SLEEVE(TM) (November 2, 1990)
  • K873368 — TECNOL COMPRESSION KNEE DRESSING (December 11, 1987)
  • K871889 — COMPRESSION LEGGING DEVICE (August 4, 1987)