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510(k) K925572

MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE by Neward Enterprises, Inc. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1993
Date Received
November 3, 1992
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 Neward Enterprises, Inc.

  • K960549 — MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE (August 29, 1996)
  • K943938 — MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE (May 3, 1995)
  • K934011 — MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE (May 4, 1994)
  • K913324 — MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT (June 22, 1992)
  • K910815 — CR SPIRAL ELECTRODE (December 10, 1991)
  • K890307 — MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE (March 31, 1989)
  • K840403 — VENA * BRIDGE (March 12, 1984)

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)