ARGUS PB-3000
FDA 510(k) clearance K221056 · decided 2023-07-06
Clearance details
- K-number
- K221056
- Device name
- ARGUS PB-3000
- Applicant
- Schiller AG
- Decision
- Substantially Equivalent
- Date received
- 2022-04-11
- Decision date
- 2023-07-06
- Days to decision
- 451 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Baar, CH
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Schiller AG
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006 recall (Z-2672-2025) | Schiller, Ag | 2025-09-29 |