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510(k) K061102

PRIMA ANAESTHESIA MACHINE by Penlon , Ltd. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2006
Date Received
April 19, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type

Other clearances by Penlon , Ltd.

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  • K002343 — SIGMA DELTA (June 8, 2001)
  • K961468 — QUIK-FIL VAPORIZER KEYED FILLER (July 16, 1996)
  • K960944 — PPV VAPORIZER (MODIFICATION) (April 2, 1996)
  • K953179 — CLM LARYNGOSCOPE (October 6, 1995)
  • K942545 — SIGMA ELITE (February 3, 1995)
  • K936046 — SIGMA ELITE (November 4, 1994)
  • K902381 — PENLON BREATHING SYSTEM PRESSURE MONITOR (August 17, 1990)

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