FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADULT MASKS & PEDIATRIC MASKS
K Number: K810340
·
Decision Mar 17, 1981
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
11
Review Days
35
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ADULT MASKS & PEDIATRIC MASKS
- K Number
- K810340
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Todd Industries, Inc.
- Date Received
- February 10, 1981
- Decision Date
- March 17, 1981
- Product Code
- BYG
- 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYG), ordered by most recent decision date.
FIRST AID KIT(S)
FDA 510(k)
FDA Class 1
·Anesthesiology
HANS RUDOLPH NASAL CPAP MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
DISPOSABLE, CPAP OXYGEN MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
FDA 510(k)
FDA Class 1
·Anesthesiology
WESTMED PEDIATRIC AND ADULT AEROSOL MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Todd Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K810343 | NEBULIZERS | Mar 17, 1981 | Substantially Equivalent |
| K810342 | NASAL CANNULA | 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 |