FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
K Number: K953039
·
Decision Sep 15, 1995
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
3
Review Days
94
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
- VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
- K Number
- K953039
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dadsun Corp., Ltd.
- Date Received
- June 13, 1995
- Decision Date
- September 15, 1995
- 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
WESTMED PEDIATRIC AND ADULT AEROSOL MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
JEMSDAL MASK
FDA 510(k)
FDA Class 1
·Anesthesiology