Atlas FDA

MODEL 250CX SERIES MATERNAL/FETAL MONITOR

FDA 510(k) clearance K072976 · decided 2007-12-20

Clearance details

K-number
K072976
Device name
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
Applicant
GE Healthcare
Decision
Substantially Equivalent
Date received
2007-10-25
Decision date
2007-12-20
Days to decision
56 days
Clearance type
Special
Product code
HGM
Device class
2
Regulation number
884.2740
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Laurel, MD, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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Novii+ Wireless Patch System (K231964)Datex Ohmeda2023-12-08
Bloomlife MFM-Pro (K222327)Bloom Technologies NV2023-02-13
Mural Perinatal Surveillance (K220732)Ge Medical Systems Information Technologies, Inc.2022-06-23
Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (K200975)Huntleigh Healthcare Limited2020-06-24
IntelliSpace Perinatal Rev.K.00 (K173941)Philips Medizin Systeme Boeblingen GmbH2018-09-10
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 (K173042)Edan Instruments, Inc.2018-08-30

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Senographe Pristina 3D (P130020/S005)GE Healthcare2025-11-21
Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011)GE Healthcare2025-02-04
Senographe Pristina 3D and SenoClaire (P130020/S004)GE Healthcare2021-03-23
Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010)GE Healthcare2018-08-24
Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009)GE Healthcare2018-05-11
Senographe Pristina 3D (P130020/S003)GE Healthcare2017-12-28
Invenia ABUS Autoated Breast Ultrasound System (P110006/S008)GE Healthcare2017-09-07
Invenia ABUS - Automated Breast Ultrasound System (P110006/S007)GE Healthcare2017-05-01