Gemscom Series 300 12-LEAD ECG (12-LEAD Option)
FDA 510(k) K921929 · General Devices
510(k) numberK921929
Submission
- Device name
- Gemscom Series 300 12-LEAD ECG (12-LEAD Option)
- Applicant
- General Devices
Bogota, NJ, US - Received
- April 24, 1992
- Decision date
- September 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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More from AliveCor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K013533 | EMS Telemedicine Option (for Gems Series 4000)DRG · Traditional | 01/18/2002SE |
| K002089 | Rosetta-Lt/Rosetta-RxDRG · Traditional | 11/21/2000SE |
| K993202 | EIM-107 Prep-CheckGZO · Traditional | 12/17/1999SE |
| K940009 | Gemscom Series 6000, Models 6100, 6200 & 6300DRG · Traditional | 04/14/1995SE |
| K935839 | Gemscom Series 5000,DRG · Traditional | 11/10/1994SE |
| K914889 | Gemscom Series 3000DRG · Traditional | 03/04/1992SE |
| K912008 | Tru-View Multi-Channel DisplayDRT · Traditional | 10/09/1991SE |
| K896153 | Modified DR-2C/PMC 100DSH · Traditional | 01/19/1990SE |
| K862596 | DR-2C (Modification)DSF · Traditional | 09/26/1986SE |
| K844650 | DR-2CDXJ · Traditional | 01/22/1985SE |
Questions and answers
When was Gemscom Series 300 12-LEAD ECG (12-LEAD Option) cleared by the FDA?
Gemscom Series 300 12-LEAD ECG (12-LEAD Option) (K921929) received a 510(k) decision of Substantially Equivalent on September 18, 1992, 147 days after the submission was received.
What is the product code of K921929?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.