FDA Product Code
FDA Product Code DRW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2350
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K033513 | EASI ECG ALGORITHM | Philips Medical Systems | 2004-01-15 | Traditional | PDF ↗ |
| K020456 | EASI 12 LEAD ALGORITHM | Philips Medical Systems | 2002-07-09 | Special | PDF ↗ |
| K930786 | EPCOR | Siemens Medical Solutions USA, Inc. | 1994-09-26 | Traditional | PDF ↗ |
| K872781 | EASI LEAD SYSTEM CABLE ASSEMBLY | Totemite Medical Electronics | 1987-12-29 | Traditional | PDF ↗ |
| K861981 | ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR | Vital Signs, Inc. | 1986-08-25 | Traditional | PDF ↗ |
| K851632 | PCX-100 PATIENT INPUT LEADWIRE | Eaton Medical Group | 1985-11-08 | Traditional | PDF ↗ |
| K851627 | KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR | Eaton Medical Group | 1985-11-08 | Traditional | PDF ↗ |
| K761210 | LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) | Physio-Control Corp. | 1976-12-21 | Traditional | PDF ↗ |
Product code DRW · Class II · Cardiovascular. Data: openFDA.