Electrocardiograph Lead Switching Adaptor
FDA 510(k) K861981 · Vital Signs, Inc.
510(k) numberK861981
Submission
- Device name
- Electrocardiograph Lead Switching Adaptor
- Applicant
- Vital Signs, Inc.
Totowa, NJ, US - Received
- May 22, 1986
- Decision date
- August 25, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRW – Adaptor, Lead Switching, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2350
- Specialty
- Cardiovascular
Other 510(k)s with product code DRW
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|---|---|---|---|
| K033513 | Easi ECG AlgorithmDRW · Traditional | Philips Medical Systems | 01/15/2004SE |
| K020456 | Easi 12 Lead AlgorithmDRW · Special | Philips Medical Systems | 07/09/2002SE |
| K930786 | EpcorDRW · Traditional | Siemens Medical Solutions USA, Inc. | 09/26/1994SE |
| K872781 | Easi Lead System Cable AssemblyDRW · Traditional | Totemite Medical Electronics | 12/29/1987SE |
| K851632 | PCX-100 Patient Input LeadwireDRW · Traditional | Eaton Medical Group | 11/08/1985SE |
| K851627 | KBX-20 Outboard Keyboard Access. for G-2000 ElectrDRW · Traditional | Eaton Medical Group | 11/08/1985SE |
| K761210 | Limb Lead Sel. (ECG Lead Switching Ad.)DRW · Traditional | Physio-Control Corp. | 12/21/1976SE |
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Questions and answers
When was Electrocardiograph Lead Switching Adaptor cleared by the FDA?
Electrocardiograph Lead Switching Adaptor (K861981) received a 510(k) decision of Substantially Equivalent on August 25, 1986, 95 days after the submission was received.
What is the product code of K861981?
The FDA product code is DRW – Adaptor, Lead Switching, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2350.