FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNETEC
K Number: K002817
·
Decision May 2, 2001
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
43
Review Days
233
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Basic Information
- Device Name
- SYNETEC
- K Number
- K002817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ela Medical, Inc.
- Date Received
- September 11, 2000
- Decision Date
- May 2, 2001
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Ela Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042002 | SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER | Oct 20, 2004 | Substantially Equivalent |
| K032466 | SPIDERVIEW | Aug 22, 2003 | Substantially Equivalent |
| K993448 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | Apr 10, 2000 | Substantially Equivalent - Subject to Tracking Reg. |
| K000029 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | Apr 4, 2000 | Substantially Equivalent |
| K990727 | SYNEFLASH & SYNEVIEW | Nov 26, 1999 | Substantially Equivalent |
| K972574 | STELA MODEL UJ45 PACING LEADS | Jan 8, 1998 | Substantially Equivalent - Subject to Tracking Reg. |
| K970072 | OPUS S MODEL 4121 AND 4124 PACEMAKERS | Aug 29, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K963738 | STELA MODEL BJ44 AND BJ45 PACING LEADS | May 23, 1997 | Substantially Equivalent - Subject to Tracking & PMS |
| K952364 | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) | Sep 1, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K952363 | OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) | Aug 15, 1995 | Substantially Equivalent |