Sonicaid System 8002

FDA 510(k) K992607 · Oxford Instruments Medical Systems

Substantially Equivalent

510(k) numberK992607

Submission

Device name
Sonicaid System 8002
Applicant
Oxford Instruments Medical Systems
Crofton, MD, US
Received
August 3, 1999
Decision date
April 27, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HGM – System, Monitoring, Perinatal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2740
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HGM

510(k)DeviceApplicantDecision
K254036Novii+ Wireless Patch SystemHGM · Traditional Datex Ohmeda, Inc.08/10/2026SE
K253021ANNE MaternalHGM · Traditional Sibel Health, Inc.02/26/2026SE
K250777Sonicaid Team3HGM · Traditional Huntleigh Healthcare , Ltd.09/19/2025SE
K241882Fetal & Maternal Monitor (F15A, F15A Air)HGM · Traditional Edan Instruments, Inc.08/27/2025SE
K241368Sonicaid Team3HGM · Traditional Huntleigh Healthcare , Ltd.02/03/2025SE
K241009PeriCALM Patterns 3.0HGM · Traditional Perigen, Inc.01/10/2025SE
K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…HGM · Traditional Philips Medizin Systeme Boeblingen GmbH07/02/2024SE
K231964Novii+ Wireless Patch SystemHGM · Traditional Datex Ohmeda12/08/2023SE
K222327Bloomlife MFM-ProHGM · Traditional Bloom Technologies NV02/13/2023SE
K220732Mural Perinatal SurveillanceHGM · Traditional Ge Medical Systems Information Technologies, Inc.06/23/2022SE

More from Ge Medical Systems Information Technologies, Inc.

510(k)DeviceDecision
K984052Synergy Iom SystemIKN · Traditional 05/17/1999SE
K970902Medilog FD4DSH · Traditional 05/05/1997SE
K961638Medilog Mpa-SOLV · Traditional 01/17/1997SE
K943862Sonicaid Model MR-63 Ambulatory ECG RecorderDSH · Traditional 06/07/1995SE

Questions and answers

When was Sonicaid System 8002 cleared by the FDA?

Sonicaid System 8002 (K992607) received a 510(k) decision of Substantially Equivalent on April 27, 2001, 633 days after the submission was received.

What is the product code of K992607?

The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.