Home / 510(k) Clearances / K874081

510(k) K874081

ENTERSCAN by Pie Data Medical BV — Product Code LWI

K874081 is an FDA 510(k) premarket notification submitted by Pie Data Medical BV for the device "ENTERSCAN". The FDA issued a decision of Substantially Equivalent on December 31, 1987. The device falls under product code LWI (Ultrasound, Sinus), a Class II device regulated under 21 CFR 892.1560. Pie Data Medical BV has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1987
Date Received
October 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasound, Sinus
Device Class
Class II
Regulation Number
892.1560
Review Panel
EN
Submission Type

Other clearances by Pie Data Medical BV

  • K874192 — MULTIPURPOSE TRANSDUCER RANGE (July 19, 1988)
  • K870653 — ULTRASOUND LINEAR/SECTOR SCANNER 1100 (February 2, 1988)
  • K870058 — PIE MEDICAL SCANNER 1000 (February 2, 1988)
  • K871082 — FETAL CARE MONITOR ANTEPARTUM 1500 (August 4, 1987)

Other clearances for product code LWI

  • K960421 — SINUSCAN 102/SINUSPRINT (April 16, 1997)
  • K960044 — ULTRAMAX/MODEL NUMBER A1 (August 2, 1996)
  • K960241 — CPR GENERAL SURGERY TRAY (March 22, 1996)

FDA data resources