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510(k) K852704

TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT by Clincal Instruments Corp. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1985
Date Received
June 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Monitoring, Perinatal
Device Class
Class II
Regulation Number
884.2740
Review Panel
OB
Submission Type

Other clearances by Clincal Instruments Corp.

  • K902327 — EMBOLECTOMY CATHETER (February 25, 1991)
  • K860742 — CAROTID BYPASS SHUNT (May 28, 1986)
  • K860743 — CAROTID BYPASS SHUNT WITH SAMPLING ARM (May 28, 1986)
  • K844918 — OCCLUSION & OCCLUSION-IRRIGATION (August 5, 1985)
  • K821220 — MULTILUMEN INTRAVENOUS INFUSION CATHETER (July 9, 1982)
  • K790034 — INTRODUCERS (February 1, 1979)
  • K771043 — SWAN GANZ (December 20, 1977)

Other clearances for product code HGM

  • K253021 — ANNE Maternal (February 26, 2026)
  • K250777 — Sonicaid Team3 (September 19, 2025)
  • K241882 — Fetal & Maternal Monitor (F15A, F15A Air) (August 27, 2025)
  • K241368 — Sonicaid Team3 (February 3, 2025)
  • K241009 — PeriCALM Patterns 3.0 (January 10, 2025)
  • K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) (July 2, 2024)
  • K231964 — Novii+ Wireless Patch System (December 8, 2023)
  • K222327 — Bloomlife MFM-Pro (February 13, 2023)
  • K220732 — Mural Perinatal Surveillance (June 23, 2022)
  • K200975 — Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (June 24, 2020)