FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIEMENS SERVO ULTRA NEBULIZER 345
K Number: K960854
·
Decision Dec 23, 1996
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
8
Review Days
297
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Basic Information
- Device Name
- SIEMENS SERVO ULTRA NEBULIZER 345
- K Number
- K960854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pacesetter, Inc.
- Date Received
- March 1, 1996
- Decision Date
- December 23, 1996
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K972814 | LOCATOR MODEL 4036 | Feb 23, 1998 | Substantially Equivalent - Subject to Tracking Reg. |
| K954714 | AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) | Feb 1, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K954551 | DF-1 TERMINAL CAP | Dec 26, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K951950 | PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING | Aug 31, 1995 | Unknown |
| K952206 | PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING | Aug 31, 1995 | Unknown |
| K951087 | TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD | Jun 29, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K950140 | IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 | Apr 6, 1995 | Substantially Equivalent |