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510(k) K895323

MODEL DT-BAL, BALANCE SAVER by Spectramed, Inc. — Product Code KXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
August 29, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Spectramed, Inc.

  • K896122 — AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED (January 19, 1990)
  • K892941 — CCO SYSTEM MODEL SP1467,SP5567,SP6267 (November 6, 1989)
  • K894362 — MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP (August 15, 1989)
  • K881857 — AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. (February 1, 1989)
  • K885235 — SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. (January 25, 1989)
  • K881825 — MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH (September 28, 1988)
  • K875337 — HEPARIN COATED LUMINAL PACING CATHETER (May 25, 1988)
  • K880740 — MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE (March 22, 1988)
  • K873168 — SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS (January 12, 1988)
  • K871573 — CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS (September 16, 1987)

Other clearances for product code KXO

  • K991235 — SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUP (July 8, 1999)
  • K982565 — EASY TRANS TIP (September 22, 1998)
  • K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUP (July 14, 1998)
  • K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (January 22, 1997)
  • K961290 — IUP - TIP TRANS, IUP - PROXI TRANS (October 15, 1996)
  • K950498 — LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER (July 24, 1995)
  • K950708 — LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 (May 25, 1995)
  • K922323 — MX4042/MC4044 SERIES SIMULCATH(TM) (June 14, 1994)
  • K920044 — DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT (April 3, 1992)
  • K910742 — MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER (January 14, 1992)