FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
SONACOLOR 6100
K Number: K801647
·
Decision Aug 20, 1980
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
11
Review Days
33
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SONACOLOR 6100
- K Number
- K801647
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Carolina Medical Electronics
- Date Received
- July 18, 1980
- Decision Date
- August 20, 1980
- Product Code
- DXY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXY), ordered by most recent decision date.
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
FDA 510(k)
FDA Class 3
·Cardiovascular
OPUS S MODEL 4121 AND 4124 PACEMAKERS
FDA 510(k)
FDA Class 3
·Cardiovascular
PIKOS LP 01, PIKOS LP E01
FDA 510(k)
FDA Class 3
·Cardiovascular
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Carolina Medical Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K914200 | VASCUMAP MEDICAL AIR PLETHYSMOGRAPH | Nov 7, 1991 | Substantially Equivalent |
| K874684 | TC2-64B TRANSCRANIAL DOPPLER | Apr 25, 1988 | Substantially Equivalent |
| K874685 | TRANS-SCAN 3-D TRANSCRANIAL DOPPLER | Apr 25, 1988 | Substantially Equivalent |
| K864624 | PROBE, UPTAKE, NUCLEAR | Aug 10, 1987 | Substantially Equivalent |
| K843891 | DOPSCAN PLUS DS1060 | Jan 9, 1985 | Substantially Equivalent |
| K837329 | SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND | Jun 7, 1983 | Substantially Equivalent |
| K820272 | CLINIFLOW II, #701, ELECTROMAGN. BLD. SY | Mar 12, 1982 | Substantially Equivalent |
| K810561 | DOPSCAN MODEL 1050 | Apr 10, 1981 | Substantially Equivalent |
| K792540 | SONACOLOR 6000 | Jan 17, 1980 | Substantially Equivalent |
| K772015 | PATIENT HEATER SYSTEM, MODEL PH112 | Nov 15, 1977 | Substantially Equivalent |