Adaptor, Lead Switching, Electrocardiograph
The Electrocardiograph Lead Switching Adaptor is a cardiovascular accessory device used to select or switch between different electrode lead configurations in electrocardiographic monitoring or recording systems. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRW and it is regulated under 21 CFR 870.2350 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DRW
- Device Class
- FDA class 2
- Regulation Number
- 870.2350
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K033513 | EASI ECG ALGORITHM | Jan 15, 2004 | Substantially Equivalent | Philips Medical Systems |
| K020456 | EASI 12 LEAD ALGORITHM | Jul 09, 2002 | Substantially Equivalent | Philips Medical Systems |
| K930786 | EPCOR | Sep 26, 1994 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K872781 | EASI LEAD SYSTEM CABLE ASSEMBLY | Dec 29, 1987 | Substantially Equivalent | Totemite Medical Electronics |
| K861981 | ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR | Aug 25, 1986 | Substantially Equivalent | Vital Signs, Inc. |
| K851632 | PCX-100 PATIENT INPUT LEADWIRE | Nov 08, 1985 | Substantially Equivalent | Eaton Medical Group |
| K851627 | KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR | Nov 08, 1985 | Substantially Equivalent | Eaton Medical Group |
| K761210 | LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) | Dec 21, 1976 | Substantially Equivalent | Physio-Control Corp. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.