EASI ECG ALGORITHM
FDA 510(k) clearance K033513 · decided 2004-01-15
Clearance details
- K-number
- K033513
- Device name
- EASI ECG ALGORITHM
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2003-11-06
- Decision date
- 2004-01-15
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- DRW
- Device class
- 2
- Regulation number
- 870.2350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Philips Medical Systems
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 |
|---|---|---|
| EASI 12 LEAD ALGORITHM (K020456) | Philips Medical Systems | 2002-07-09 |
| EPCOR (K930786) | Siemens Medical Solutions USA, Inc. | 1994-09-26 |
| EASI LEAD SYSTEM CABLE ASSEMBLY (K872781) | Totemite Medical Electronics | 1987-12-29 |
| ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR (K861981) | Vital Signs, Inc. | 1986-08-25 |
| PCX-100 PATIENT INPUT LEADWIRE (K851632) | Eaton Medical Group | 1985-11-08 |
| KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR (K851627) | Eaton Medical Group | 1985-11-08 |
| LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) (K761210) | Physio-Control Corp. | 1976-12-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |
| HeartStart FRx Defibrillator (861304) (P180028/S011) | Philips Medical Systems | 2021-11-15 |
| HeartStart FRx Defibrillator (861304) (P180028/S010) | Philips Medical Systems | 2021-09-24 |