510(k) K761210
- Device
- LIMB LEAD SEL. (ECG LEAD SWITCHING AD.)
- Applicant
- Physio-Control Corp.
- 510(k) number
- K761210
- Product code
- DRW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-21
- Date received
- 1976-12-07
- Regulation
- 870.2350
- Classification name
- Adaptor, Lead Switching, Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010703925
- 3013500228
- 1218950
- 3012528160
- 3013596024
- 3000126629
- 3016618143
- 9610816
- 3009077524
- 3003263092
- 3016701404
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DRW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K033513 | EASI ECG ALGORITHM | Philips Medical Systems | 2004-01-15 |
| K020456 | EASI 12 LEAD ALGORITHM | Philips Medical Systems | 2002-07-09 |
| K930786 | EPCOR | Siemens Medical Solutions USA, Inc. | 1994-09-26 |
| K872781 | EASI LEAD SYSTEM CABLE ASSEMBLY | Totemite Medical Electronics | 1987-12-29 |
| K861981 | ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR | Vital Signs, Inc. | 1986-08-25 |
| K851627 | KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR | Eaton Medical Group | 1985-11-08 |
| K851632 | PCX-100 PATIENT INPUT LEADWIRE | Eaton Medical Group | 1985-11-08 |