FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S
K Number: K854551
·
Decision Dec 19, 1985
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
49
Review Days
36
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Basic Information
- Device Name
- MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S
- K Number
- K854551
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5640
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medipart Jerry Alexander
- Date Received
- November 13, 1985
- Decision Date
- December 19, 1985
- Product Code
- CCQ
- 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 |
|---|---|---|---|
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | FDA class 1 | Anesthesiology |
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Other Clearances by Medipart Jerry Alexander
| K Number | Device Name | ||
|---|---|---|---|
| K896885 | DISPOSABLE RESPIRTORY KIT (MP-200) | Feb 26, 1990 | Substantially Equivalent |
| K896125 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M | Feb 1, 1990 | Substantially Equivalent |
| K896124 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 | Jan 22, 1990 | Substantially Equivalent |
| K896475 | DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD | Jan 22, 1990 | Substantially Equivalent |
| K896476 | DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD | Jan 22, 1990 | Substantially Equivalent |
| K894138 | MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD | Sep 26, 1989 | Substantially Equivalent |
| K893532 | RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963 | Aug 21, 1989 | Substantially Equivalent |
| K862786 | MP-50T DISPOSABLE BREATHING CIRCUIT FILTER | Aug 1, 1986 | Substantially Equivalent |
| K862795 | MP-070-M RADIOAEROSOL KIT | Aug 1, 1986 | Substantially Equivalent |
| K862791 | MP-30XM-IE FACE MASK AND FILTER KIT | Aug 1, 1986 | Substantially Equivalent |