Ekosector I
FDA 510(k) K761030 · Smithkline Diagnostics, Inc.
510(k) numberK761030
Submission
- Device name
- Ekosector I
- Applicant
- Smithkline Diagnostics, Inc.
Mchenry, IL, US - Received
- November 12, 1976
- Decision date
- December 13, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HGM – System, Monitoring, Perinatal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2740
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K254036 | Novii+ Wireless Patch SystemHGM · Traditional | Datex Ohmeda, Inc. | 08/10/2026SE |
| K253021 | ANNE MaternalHGM · Traditional | Sibel Health, Inc. | 02/26/2026SE |
| K250777 | Sonicaid Team3HGM · Traditional | Huntleigh Healthcare , Ltd. | 09/19/2025SE |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air)HGM · Traditional | Edan Instruments, Inc. | 08/27/2025SE |
| K241368 | Sonicaid Team3HGM · Traditional | Huntleigh Healthcare , Ltd. | 02/03/2025SE |
| K241009 | PeriCALM Patterns 3.0HGM · Traditional | Perigen, Inc. | 01/10/2025SE |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…HGM · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/02/2024SE |
| K231964 | Novii+ Wireless Patch SystemHGM · Traditional | Datex Ohmeda | 12/08/2023SE |
| K222327 | Bloomlife MFM-ProHGM · Traditional | Bloom Technologies NV | 02/13/2023SE |
| K220732 | Mural Perinatal SurveillanceHGM · Traditional | Ge Medical Systems Information Technologies, Inc. | 06/23/2022SE |
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| K934863 | Flexsure HPLYR · Traditional | 05/18/1994SE |
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| K854723 | SKD Electrochemical System (Ecs)CEM · Traditional | 03/05/1986SE |
| K852841 | Rapid Direct Strep a Latex Agglutination TestGTZ · Traditional | 07/24/1985SE |
| K821884 | Gastroccult TMKHE · Traditional | 10/08/1982SE |
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Questions and answers
When was Ekosector I cleared by the FDA?
Ekosector I (K761030) received a 510(k) decision of Substantially Equivalent on December 13, 1976, 31 days after the submission was received.
What is the product code of K761030?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.