FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
SYSTEM 22 PAEDIATRIC MASK
K Number: K940888
·
Decision Apr 19, 1994
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
9
Review Days
53
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Basic Information
- Device Name
- SYSTEM 22 PAEDIATRIC MASK
- K Number
- K940888
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medic-Aid , Ltd.
- Date Received
- February 25, 1994
- Decision Date
- April 19, 1994
- 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.
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VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
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WESTMED PEDIATRIC AND ADULT AEROSOL MASK
FDA 510(k)
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Other Clearances by Medic-Aid , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K991685 | HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR | Aug 13, 1999 | Substantially Equivalent |
| K981772 | HALOLITE AAD SYSTEM | Nov 3, 1998 | Substantially Equivalent |
| K971933 | PORT-NEB | Aug 1, 1997 | Substantially Equivalent |
| K934749 | FREEWAY LITE NEBULIZER COMPRESSOR | Jul 25, 1994 | Substantially Equivalent |
| K940887 | SYSTEM 22 ADULT MASK | Apr 19, 1994 | Substantially Equivalent |
| K933535 | VENTSTREAM DRUG NEBULIZER | Jan 24, 1994 | Substantially Equivalent |
| K924123 | SIDESTREAM DISPOSABLE | Nov 16, 1992 | Substantially Equivalent |
| K914152 | SIDESTREAM DRUG NEBULIZER | May 5, 1992 | Substantially Equivalent |