EASI LEAD SYSTEM CABLE ASSEMBLY
FDA 510(k) clearance K872781 · decided 1987-12-29
Clearance details
- K-number
- K872781
- Device name
- EASI LEAD SYSTEM CABLE ASSEMBLY
- Applicant
- Totemite Medical Electronics
- Decision
- Substantially Equivalent
- Date received
- 1987-07-14
- Decision date
- 1987-12-29
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- DRW
- Device class
- 2
- Regulation number
- 870.2350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Blaine, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EASI ECG ALGORITHM (K033513) | Philips Medical Systems | 2004-01-15 |
| EASI 12 LEAD ALGORITHM (K020456) | Philips Medical Systems | 2002-07-09 |
| EPCOR (K930786) | Siemens Medical Solutions USA, Inc. | 1994-09-26 |
| 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.