FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PACEMAKER 208S
K Number: K770005
·
Decision Feb 24, 1977
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
11
Review Days
52
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
- PACEMAKER 208S
- K Number
- K770005
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Elema-Schonander, Inc.
- Date Received
- January 3, 1977
- Decision Date
- February 24, 1977
- 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 Elema-Schonander, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934944 | MPQ-42 | Dec 15, 1993 | Substantially Equivalent |
| K904103 | SEP 90 | Nov 20, 1990 | Substantially Equivalent |
| K903576 | PUCK 90M | Sep 4, 1990 | Substantially Equivalent |
| K842903 | SEP PROGRAMMER FOR PUCK U & UD FILMCHANG | Aug 21, 1984 | Substantially Equivalent |
| K842911 | PUCK U & UD CUTFILM CHANGERS | Aug 21, 1984 | Substantially Equivalent |
| K840389 | SEP PROGRAMMER SEP-M/SINGLE-PLANE & | Feb 21, 1984 | Substantially Equivalent |
| K790792 | PULSE GENERATOR MODEL 637 | Oct 12, 1979 | Substantially Equivalent |
| K790670 | PULSE GENERATOR MODEL 629 | Jun 27, 1979 | Substantially Equivalent |
| K781178 | PULSE GENERATOR MODEL 208 | Sep 7, 1978 | Substantially Equivalent |
| K770135 | LEAD MODIFICATION | Feb 7, 1977 | Substantially Equivalent |