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510(k) K912747

LULMITEX NEONATAL TRANSILLUMINATOR by Lumitex, Inc. — Product Code HJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1991
Date Received
June 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transilluminator, Battery-Powered
Device Class
Class I
Regulation Number
886.1945
Review Panel
OP
Submission Type

Other clearances by Lumitex, Inc.

  • K120820 — GIRAFFE BLUE SPOT PT LITE (June 8, 2012)
  • K053568 — BILISOFT PHOTOTHERAPY SYSTEM (April 17, 2006)

Other clearances for product code HJN

  • K941035 — VENOSCOPE (May 16, 1994)
  • K901309 — SYLVAN PEDIASCAN 200 TRANSILLUMINATOR (May 24, 1990)