EarlyVue VS30
FDA 510(k) clearance K190624 · decided 2019-10-27
Clearance details
- K-number
- K190624
- Device name
- EarlyVue VS30
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2019-03-11
- Decision date
- 2019-10-27
- Days to decision
- 230 days
- Clearance type
- Traditional
- Product code
- DSJ
- Device class
- 2
- Regulation number
- 870.1100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Philips Medizin Systeme Boeblingen GmbH
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SureSigns VS3; SureSigns VS4 (K163649) | Philips Medical Systems | 2017-03-31 |
| SureSigns VS3, SureSigns VS4 (K151761) | Phillips Medical Systems | 2015-09-29 |
| SURESIGNS VS3, SURESIGNS VS4 (K133961) | Philips Medical Systems | 2014-06-26 |
| SAMS 8000 CARDIOPLEGIA MONITOR (K960916) | 3M Health Care, Sarns | 1996-06-04 |
| KELLER VITAL SIGNS MONITOR - KMS-890 (K910262) | Keller Medical Specialties Products, Inc. | 1991-04-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 recall (Z-2654-2023) | Philips North America Llc | 2023-09-29 |
| EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) an recall (Z-2655-2023) | Philips North America Llc | 2023-09-29 |
| EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 86 recall (Z-1645-2023) | Philips North America Llc | 2023-05-26 |