Cardiobeeper Memory Monitor
FDA 510(k) K813101 · Survival Technology, Inc.
510(k) numberK813101
Submission
- Device name
- Cardiobeeper Memory Monitor
- Applicant
- Survival Technology, Inc.
Mchenry, IL, US - Received
- November 3, 1981
- Decision date
- November 27, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXY – Implantable Pacemaker Pulse-Generator
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3610
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993434 | Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-A, Pikos E01-ADXY · Special | Biotronik, Inc. | 11/10/1999SE |
| K970072 | Opus S Model 4121 and 4124 PacemakersDXY · Traditional | Ela Medical, Inc. | 08/29/1997ST |
| K945627 | Pikos LP 01, Pikos LP E01DXY · Traditional | Biotronik, Inc. | 03/04/1996SESP |
| K954092 | Alternate Sterlization Process & Modified DF-1 Lead Connector (Modification)DXY · Traditional | Medtronic Vascular | 12/15/1995ST |
| K953866 | Minix 834M & Minix ST 8331M Pulse Generators (Modification)DXY · Traditional | Medtronic Vascular | 12/15/1995ST |
| K953417 | Miniflex Model 340, 341, and 342 Pulse GeneratorsDXY · Traditional | Cook Pacemaker Corp. | 09/29/1995ST |
| K952328 | Nanos, Pikos 01/E01, 01-A, E01-B, LP 01/LP E01DXY · Traditional | Biotronik, Inc. | 09/29/1995ST |
| K952364 | Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)DXY · Traditional | Ela Medical, Inc. | 09/01/1995ST |
| K940039 | Pellethane 75DDXY · Traditional | Medtronic Vascular | 07/12/1995ST |
| K950751 | Tecothane 75D Polyurethane Resin for Pulse Generator Connector ModulesDXY · Traditional | Medtronic Vascular | 05/15/1995ST |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K925535 | Cardiobeeper(R) Cb-IiaDXH · Traditional | 01/28/1993SE |
| K894799 | Cardiobeeper Memory Monitor CB 600 SeriesDXH · Traditional | 10/03/1989SE |
| K890461 | Cardiobeeper IVDXH · Traditional | 02/23/1989SE |
| K883843 | Cardiobeeper IIDXH · Traditional | 11/09/1988SE |
| K883614 | Cytoguard(R)FMF · Traditional | 09/15/1988SE |
| K880300 | Cardiobeeper(R) IIIDXH · Traditional | 05/12/1988SE |
| K844966 | Cardiobeeper Profile MonitorDXH · Traditional | 02/08/1985SE |
| K822093 | Stat-ScanDXG · Traditional | 09/21/1982SE |
| K772178 | Pacer Monitor, Pulse WidthDXH · Traditional | 12/08/1977SE |
Questions and answers
When was Cardiobeeper Memory Monitor cleared by the FDA?
Cardiobeeper Memory Monitor (K813101) received a 510(k) decision of Substantially Equivalent on November 27, 1981, 24 days after the submission was received.
What is the product code of K813101?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.