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510(k) K813327

SEPCOR TEMPERATURE MONITOR by Separation Science Corp. — Product Code KSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
November 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refrigerator, Freezer, Blood Storage
Device Class
Class II
Regulation Number
864.9700
Review Panel
HE
Submission Type

Other clearances by Separation Science Corp.

  • K820712 — SEPCOR UNIT COLLECTION MONITOR (May 7, 1982)

Other clearances for product code KSE

  • K884436 — MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 (December 2, 1988)
  • K802319 — HEMOTEMP TM (October 10, 1980)
  • K800667 — MONITEMP BLOOD PACK TEMP. MONITOR (April 16, 1980)