HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
FDA 510(k) clearance K993383 · decided 2000-02-03
Clearance details
- K-number
- K993383
- Device name
- HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
- Applicant
- Hewlett-Packard GmbH
- Decision
- Substantially Equivalent
- Date received
- 1999-10-08
- Decision date
- 2000-02-03
- Days to decision
- 118 days
- Clearance type
- Abbreviated
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hewlett-Packard 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 |
|---|---|---|
| BodyGuardian Remote Monitoring System (BGRMS v3.0) (K243349) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | 2026-01-23 |
| MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (K250356) | Infobionic, Inc. | 2025-07-29 |
| Zio AT® device (A100A1001) (K240177) | iRhythm Technologies, Inc. | 2024-10-30 |
| MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (K230265) | Infobionic, Inc. | 2023-10-06 |
| SmartCardia 7L Platform (K231276) | Smartcardia SA | 2023-08-30 |
| Unified Arrhythmia Diagnostic System PocketECG IV (K193104) | Medicalgorithmics S.A. | 2020-04-09 |
| BodyGuardian Remote Monitoring System (K192732) | Preventice Technologies, Inc. | 2020-03-26 |
| Patient Assistant Model PA97000 (K190574) | Medtronic, Inc. | 2019-09-24 |
| Liba3 System (K182532) | National Cardiac, Inc. | 2019-05-15 |
| MobileECG 2 BT (K181658) | Memtec Corporation | 2019-03-26 |
| Medicalgorithmics Unified Cardiac Rehabilitation System (K173969) | Medicalgorithmics S.A. | 2018-07-11 |
| Epicardia Anywhere (K173170) | Medicomp, Inc. | 2018-01-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub C recall (Z-1722-2025) | Philips North America Llc | 2025-05-05 |