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510(k) K090061

AIRSTRIP OB by Airstrip Technologies, LP — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2009
Date Received
January 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Airstrip Technologies, LP

  • K211949 — AirStrip ONE Web Client with Alarm Communication Management (ACM) (December 9, 2021)
  • K182226 — AirStrip RPM InvisionHeart Adapter (September 11, 2018)
  • K160862 — AirStrip RPM (September 19, 2016)
  • K143114 — Sense4Baby System Model B+ (MSA) (March 10, 2015)
  • K133450 — AIRSTRIP REMOTE PATIENT MONITORING (February 14, 2014)
  • K133394 — AIRSTRIP REMOTE PATIENT MONITORING (February 6, 2014)
  • K131786 — AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER (July 3, 2013)
  • K121712 — AIRSTRIP RPM FOR LIFENET CONSULT (November 20, 2012)
  • K122133 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING (October 2, 2012)
  • K121871 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING (July 3, 2012)

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)