DRW · Adaptor, Lead Switching, Electrocardiograph
Cardiovascular · 21 CFR 870.2350 · Class 2
Overview
| Product Code | DRW |
|---|---|
| Device Name | Adaptor, Lead Switching, Electrocardiograph |
| Regulation | 21 CFR 870.2350 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An electrocardiograph lead switching adaptor is a passive switching device to which electrocardiograph limb and chest leads may be attached. This device is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations such as leads I, II, and III.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K033513 | EASI ECG ALGORITHM | Philips Medical Systems | Jan 15, 2004 | SESE |
| K020456 | EASI 12 LEAD ALGORITHM | Philips Medical Systems | Jul 9, 2002 | SESE |
| K930786 | EPCOR | Siemens Medical Solutions USA, Inc. | Sep 26, 1994 | SESE |
| K872781 | EASI LEAD SYSTEM CABLE ASSEMBLY | Totemite Medical Electronics | Dec 29, 1987 | SESE |
| K861981 | ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR | Vital Signs, Inc. | Aug 25, 1986 | SESE |
| K851632 | PCX-100 PATIENT INPUT LEADWIRE | Eaton Medical Group | Nov 8, 1985 | SESE |
| K851627 | KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR | Eaton Medical Group | Nov 8, 1985 | SESE |
| K761210 | LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) | Physio-Control Corp. | Dec 21, 1976 | SESE |
Top Applicants
- Eaton Medical Group — 2 clearances
- Philips Medical Systems — 2 clearances
- Physio-Control Corp. — 1 clearance
- Siemens Medical Solutions USA, Inc. — 1 clearance
- Totemite Medical Electronics — 1 clearance
