Sonacolor 6100
FDA 510(k) K801647 · Carolina Medical Electronics
510(k) numberK801647
Submission
- Device name
- Sonacolor 6100
- Applicant
- Carolina Medical Electronics
Mchenry, IL, US - Received
- July 18, 1980
- Decision date
- August 20, 1980
- 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 |
|---|---|---|
| K914200 | Vascumap Medical Air PlethysmographDSB · Traditional | 11/07/1991SE |
| K874685 | Trans-Scan 3-D Transcranial DopplerIYO · Traditional | 04/25/1988SE |
| K874684 | TC2-64B Transcranial DopplerIYO · Traditional | 04/25/1988SE |
| K864624 | Probe, Uptake, NuclearIZO · Traditional | 08/10/1987SE |
| K843891 | Dopscan Plus DS1060IYO · Traditional | 01/09/1985SE |
| K837329 | Sonacolor CD, Model 6300 Cardiac Doppler Ultrasound · Traditional | 06/07/1983SE |
| K820272 | Cliniflow II, #701, Electromagn. Bld. SyDPW · Traditional | 03/12/1982SE |
| K810561 | Dopscan Model 1050DPW · Traditional | 04/10/1981SE |
| K792540 | Sonacolor 6000DXK · Traditional | 01/17/1980SE |
| K772015 | Patient Heater System, Model PH112DWJ · Traditional | 11/15/1977SE |
Questions and answers
When was Sonacolor 6100 cleared by the FDA?
Sonacolor 6100 (K801647) received a 510(k) decision of Substantially Equivalent on August 20, 1980, 33 days after the submission was received.
What is the product code of K801647?
The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.