IntelliSpace Perinatal Rev.K.00
FDA 510(k) clearance K173941 · decided 2018-09-10
Clearance details
- K-number
- K173941
- Device name
- IntelliSpace Perinatal Rev.K.00
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2017-12-26
- Decision date
- 2018-09-10
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Boeblingen, DE
- 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.
| Record | Firm | Date |
|---|---|---|
| ANNE Maternal (K253021) | Sibel Health, Inc. | 2026-02-26 |
| Sonicaid Team3 (K250777) | Huntleigh Healthcare , Ltd. | 2025-09-19 |
| Fetal & Maternal Monitor (F15A, F15A Air) (K241882) | Edan Instruments, Inc. | 2025-08-27 |
| Sonicaid Team3 (K241368) | Huntleigh Healthcare , Ltd. | 2025-02-03 |
| PeriCALM Patterns 3.0 (K241009) | Perigen, Inc. | 2025-01-10 |
| Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) (K233440) | Philips Medizin Systeme Boeblingen GmbH | 2024-07-02 |
| Novii+ Wireless Patch System (K231964) | Datex Ohmeda | 2023-12-08 |
| Bloomlife MFM-Pro (K222327) | Bloom Technologies NV | 2023-02-13 |
| Mural Perinatal Surveillance (K220732) | Ge Medical Systems Information Technologies, Inc. | 2022-06-23 |
| Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (K200975) | Huntleigh Healthcare Limited | 2020-06-24 |
| Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 (K173042) | Edan Instruments, Inc. | 2018-08-30 |
| AlertWatch:OB (K173715) | Alertwatch, Inc. | 2018-04-23 |
Recalls involving this device
No recalls on record reference this clearance.