KBX-20 Outboard Keyboard Access. for G-2000 Electr
FDA 510(k) K851627 · Eaton Medical Group
510(k) numberK851627
Submission
- Device name
- KBX-20 Outboard Keyboard Access. for G-2000 Electr
- Applicant
- Eaton Medical Group
Eaton, MI, US - Received
- April 18, 1985
- Decision date
- November 8, 1985
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K861981 | Electrocardiograph Lead Switching AdaptorDRW · Traditional | Vital Signs, Inc. | 08/25/1986SE |
| K851632 | PCX-100 Patient Input LeadwireDRW · Traditional | Eaton Medical Group | 11/08/1985SE |
| K761210 | Limb Lead Sel. (ECG Lead Switching Ad.)DRW · Traditional | Physio-Control Corp. | 12/21/1976SE |
More from Physio-Control Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K851623 | Model TRC-40 Telemetry Reciever ModuleDXH · Traditional | 01/22/1986SE |
| K851624 | Model TT-185 Telemetry TransmitterDXH · Traditional | 01/14/1986SE |
| K851625 | SCX-10 Single Channel Recorder Access. for G-2000DSF · Traditional | 11/19/1985SE |
| K851632 | PCX-100 Patient Input LeadwireDRW · Traditional | 11/08/1985SE |
| K851631 | TMX-C1/C2 Tradmill Controller Access.IOL · Traditional | 07/15/1985SE |
| K851630 | TMX-80 TreadmillIOL · Traditional | 07/09/1985SE |
| K851629 | TMX-70 TreadmillIOL · Traditional | 07/09/1985SE |
| K851628 | RMG-9 9 Remote Monitor Access. for G-2000 ElectroDXJ · Traditional | 06/27/1985SE |
| K851633 | CC-100 Clock/Calander Module Access. for G-2000 ElDPS · Traditional | 06/26/1985SE |
| K851626 | SCX-35 Three Channel Access. for Module G-2000 EleDSF · Traditional | 06/26/1985SE |
Questions and answers
When was KBX-20 Outboard Keyboard Access. for G-2000 Electr cleared by the FDA?
KBX-20 Outboard Keyboard Access. for G-2000 Electr (K851627) received a 510(k) decision of Substantially Equivalent on November 8, 1985, 204 days after the submission was received.
What is the product code of K851627?
The FDA product code is DRW – Adaptor, Lead Switching, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2350.