EarlyVue VS30
FDA 510(k) K190624 · Philips Medizin Systeme Boeblingen GmbH
510(k) numberK190624
Submission
- Device name
- EarlyVue VS30
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
Boeblingen, DE - Received
- March 11, 2019
- Decision date
- October 27, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSJ – Alarm, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1100
- Specialty
- Cardiovascular
Other 510(k)s with product code DSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163649 | SureSigns VS3; SureSigns VS4DSJ · Special | Philips Medical Systems | 03/31/2017SE |
| K151761 | SureSigns VS3, SureSigns VS4DSJ · Special | Phillips Medical Systems | 09/29/2015SE |
| K133961 | Suresigns VS3, Suresigns VS4DSJ · Traditional | Philips Medical Systems | 06/26/2014SE |
| K960916 | Sams 8000 Cardioplegia MonitorDSJ · Traditional | 3M Health Care, Sarns | 06/04/1996SE |
| K910262 | Keller Vital Signs Monitor - KMS-890DSJ · Traditional | Keller Medical Specialties Products, Inc. | 04/01/1991SE |
More from Keller Medical Specialties Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…MHX · Traditional | 02/06/2026SE |
| K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550MHX · Traditional | 10/17/2025SE |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…HGM · Traditional | 07/02/2024SE |
| K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…MHX · Traditional | 12/19/2023SE |
| K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)MHX · Traditional | 11/22/2023SE |
| K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…MHX · Traditional | 08/22/2023SE |
| K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…MHX · Traditional | 10/07/2021SE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional | 09/30/2021SE |
| K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550MHX · Abbreviated | 09/11/2020SE |
| K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…MHX · Special | 11/19/2019SE |
Questions and answers
When was EarlyVue VS30 cleared by the FDA?
EarlyVue VS30 (K190624) received a 510(k) decision of Substantially Equivalent on October 27, 2019, 230 days after the submission was received.
What is the product code of K190624?
The FDA product code is DSJ – Alarm, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1100.