FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATC OPTION FOR EVITA 2 DURA AND EVITA 4
K Number: K992608
·
Decision Aug 24, 1999
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
20
Review Days
20
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Basic Information
- Device Name
- ATC OPTION FOR EVITA 2 DURA AND EVITA 4
- K Number
- K992608
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Drager, Inc.
- Date Received
- August 4, 1999
- Decision Date
- August 24, 1999
- Product Code
- CBK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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Other Clearances by Drager, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K984577 | DRAGER OXYLOG 2000 | Jan 22, 1999 | Substantially Equivalent |
| K983219 | NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 | Dec 7, 1998 | Substantially Equivalent |
| K982789 | MEDICAL AIR COMPRESSOR, MODEL # 8413419 | Oct 29, 1998 | Substantially Equivalent |
| K980642 | EVITA 4 (8411900) | Sep 4, 1998 | Substantially Equivalent |
| K974176 | BABYLOG 8000 PLUS | Jun 17, 1998 | Substantially Equivalent |
| K971198 | BABYTHERM 8004 BABYTHERM 8010 | Oct 3, 1997 | Substantially Equivalent |
| K970165 | EVITA 2 DURA | Aug 26, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K954204 | DRAGER INCUBATOR 8000 IC | Apr 25, 1997 | Substantially Equivalent |
| K961687 | EVITA 4 | Dec 13, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K950853 | OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS | Nov 5, 1996 | Substantially Equivalent - Subject to Tracking Reg. |