FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEBULIZERS
K Number: K810343
·
Decision Mar 17, 1981
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
11
Review Days
35
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Basic Information
- Device Name
- NEBULIZERS
- K Number
- K810343
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5640
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Todd Industries, Inc.
- Date Received
- February 10, 1981
- Decision Date
- March 17, 1981
- 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 Todd Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K810342 | NASAL CANNULA | Mar 17, 1981 | Substantially Equivalent |
| K810340 | ADULT MASKS & PEDIATRIC MASKS | Mar 17, 1981 | Substantially Equivalent |
| K810362 | CORRUGATED FLEX TUBING | Mar 17, 1981 | Substantially Equivalent |
| K810373 | VENTURI MASK/DELIVERY SYSTEM #'S | Mar 17, 1981 | Substantially Equivalent |
| K810361 | CONNECTOR ADAPTERS | Mar 17, 1981 | Substantially Equivalent |
| K810344 | OXYGEN TUBING | Mar 17, 1981 | Substantially Equivalent |
| K810341 | LIFELINE IPPB SET-UP | Mar 17, 1981 | Substantially Equivalent |
| K810339 | NOSECLIP #6118 | Mar 17, 1981 | Substantially Equivalent |
| K810430 | VENTURI MASK/DELIVERY SYSTEM #6078 | Mar 13, 1981 | Substantially Equivalent |
| K810374 | CORRUGATED FLEX TUBING #6000, | Mar 13, 1981 | Substantially Equivalent |