FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
MEDIX ELECTRONIC NEBULIZING SYSTEM
K Number: K853071
·
Decision Aug 29, 1985
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
5
Review Days
37
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Basic Information
- Device Name
- MEDIX ELECTRONIC NEBULIZING SYSTEM
- K Number
- K853071
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5640
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medix Corp.
- Date Received
- July 23, 1985
- Decision Date
- August 29, 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 Medix Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K921273 | EASIMIST ULTRASONIC NEBULIZER | Apr 1, 1994 | Substantially Equivalent |
| K914772 | MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001 | Jul 24, 1992 | Substantially Equivalent |
| K822454 | SYRINGE PUMP 209-100 | Oct 18, 1982 | Substantially Equivalent |
| K780444 | NERVTRON-RX | Apr 19, 1978 | Substantially Equivalent |