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510(k) K802978

TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 by Brattle Instrument Corp. — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1981
Date Received
November 21, 1980
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 Brattle Instrument Corp.

  • K810588 — SYNCHRONIZER #208 (April 10, 1981)
  • K781681 — PHIPIOLOGICAL SYNCHRONIZER PART#205 (October 17, 1978)
  • K770692 — MONITOR, FETAL, NO. L04-1100 (April 26, 1977)
  • K770297 — FETAL MONITOR, PART #100-11009 (March 9, 1977)
  • K770296 — FETAL MONITOR, PART #101-11009 (March 9, 1977)
  • K770295 — ABDOMINAL ECG PROCESSOR FOR FETAL MONI. (March 9, 1977)

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  • K861861 — 515A NEO-TRAK NEONATAL MONITOR (July 10, 1986)
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