FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEBULIZER ACCESSORY FOR SERVO VENTILL
K Number: K832898
·
Decision Nov 25, 1983
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
63
Review Days
91
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Basic Information
- Device Name
- NEBULIZER ACCESSORY FOR SERVO VENTILL
- K Number
- K832898
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Siemens Elema AB
- Date Received
- August 26, 1983
- Decision Date
- November 25, 1983
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K010925 | SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E | Dec 18, 2001 | Substantially Equivalent |
| K002137 | CATHCOR DESKTOP | Oct 5, 2000 | Substantially Equivalent |
| K001315 | MODIFICATION TO KION ANESTHESIA SYSTEM | May 26, 2000 | Substantially Equivalent |
| K970839 | SERVO VENTILATOR 300A | Oct 14, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K960010 | SERVO VENTILATOR 300 COMPUTER INTERFACE | Oct 25, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K960168 | SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 | Oct 25, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K872278 | SIEMENS O2-AIR MIXER 965 | Sep 3, 1987 | Substantially Equivalent |
| K871354 | SERVO VENTILATOR 900 C/D | Jul 21, 1987 | Substantially Equivalent |