CC-100 Clock/Calander Module Access. for G-2000 El
FDA 510(k) K851633 · Eaton Medical Group
510(k) numberK851633
Submission
- Device name
- CC-100 Clock/Calander Module Access. for G-2000 El
- Applicant
- Eaton Medical Group
Eaton, MI, US - Received
- April 18, 1985
- Decision date
- June 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
More from Masimo Corporation
| 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 |
| K851627 | KBX-20 Outboard Keyboard Access. for G-2000 ElectrDRW · 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 |
| K851626 | SCX-35 Three Channel Access. for Module G-2000 EleDSF · Traditional | 06/26/1985SE |
Questions and answers
When was CC-100 Clock/Calander Module Access. for G-2000 El cleared by the FDA?
CC-100 Clock/Calander Module Access. for G-2000 El (K851633) received a 510(k) decision of Substantially Equivalent on June 26, 1985, 69 days after the submission was received.
What is the product code of K851633?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.