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510(k) K893503

SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS by Laurel Medical Corp. — Product Code HFN

K893503 is an FDA 510(k) premarket notification submitted by Laurel Medical Corp. for the device "SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS". The FDA issued a decision of Substantially Equivalent on June 12, 1989. The device falls under product code HFN (Transducer, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1989
Date Received
May 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Intrauterine
Device Class
Class II
Regulation Number
884.2700
Review Panel
OB
Submission Type

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  • K974389 — KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHE (February 19, 1998)
  • K973746 — PRE-FILLED SYRINGE FOR KOALA IUP (November 24, 1997)
  • K961424 — INTRAN 500 (July 10, 1996)
  • K954955 — STORC INTRAUTERINE PRESSURE CATHETER (April 17, 1996)
  • K955443 — INTRAN PLUS (February 20, 1996)
  • K920375 — DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER (October 27, 1992)
  • K882224 — ULTRANS DISPOSABLE INTRAUTERINE (October 12, 1989)

FDA data resources