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510(k) K861189

TECNOL SECURE-ALL FETAL MONITOR STRAP by Tecnol New Jersey Wound Care, Inc. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1986
Date Received
March 31, 1986
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 Tecnol New Jersey Wound Care, Inc.

  • K913043 — MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS (August 23, 1991)
  • K911891 — FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK (July 12, 1991)
  • K911907 — FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS (July 8, 1991)
  • K896193 — TECNOL LAZER(TM) SURGICAL MASK (February 27, 1990)
  • K894205 — TECNOL SILK STRIP (July 25, 1989)
  • K893702 — TECNOL GAITERS PRODUCT NUMBER 47725-010 (June 23, 1989)
  • K891187 — TECNOL NASO-GASTRIC TUBE HOLDER (May 30, 1989)
  • K891178 — TECNOL SECURE-ALL TUBE HOLDER (May 23, 1989)
  • K884440 — TECNOL VARIABLE TENSION BANDAGE (January 17, 1989)
  • K882640 — TECNOL SECURE-ALL PELVIC TRACTION BELT (July 27, 1988)

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)