LIMB LEAD SEL. (ECG LEAD SWITCHING AD.)
FDA 510(k) clearance K761210 · decided 1976-12-21
Clearance details
- K-number
- K761210
- Device name
- LIMB LEAD SEL. (ECG LEAD SWITCHING AD.)
- Applicant
- Physio-Control Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-12-07
- Decision date
- 1976-12-21
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- DRW
- Device class
- 2
- Regulation number
- 870.2350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.