FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HALOLITE AAD SYSTEM
K Number: K981772
·
Decision Nov 3, 1998
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
9
Review Days
168
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Basic Information
- Device Name
- HALOLITE AAD SYSTEM
- K Number
- K981772
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medic-Aid , Ltd.
- Date Received
- May 19, 1998
- Decision Date
- November 3, 1998
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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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 |
| K971933 | PORT-NEB | Aug 1, 1997 | Substantially Equivalent |
| K934749 | FREEWAY LITE NEBULIZER COMPRESSOR | Jul 25, 1994 | Substantially Equivalent |
| K940888 | SYSTEM 22 PAEDIATRIC MASK | Apr 19, 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 |