FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LITEAIRE
K Number: K993101
·
Decision Oct 26, 2000
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
15
Review Days
406
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Basic Information
- Device Name
- LITEAIRE
- K Number
- K993101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thayer Medical Corp.
- Date Received
- September 16, 1999
- Decision Date
- October 26, 2000
- 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 Thayer Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K102658 | MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS | Dec 10, 2010 | Substantially Equivalent |
| K992722 | PRIMEAIRE | Nov 10, 1999 | Substantially Equivalent |
| K972237 | HAND HELD MEDISPACER | Jul 31, 1997 | Substantially Equivalent |
| K955805 | DUAL SPRAY MINISPACER | Mar 21, 1996 | Substantially Equivalent |
| K941026 | THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR | Aug 18, 1994 | Substantially Equivalent |
| K924535 | THAYER HAND HELD M.K.I. HOLDING CHAMBER | Mar 10, 1993 | Substantially Equivalent |
| K914283 | THAYER EXPANSION CHAMBER METERED DOSE INHALER | Feb 26, 1992 | Substantially Equivalent |
| K904917 | THAYER MIP ADAPTER | Jan 28, 1991 | Substantially Equivalent |
| K901739 | THAYER METERED DOSE INHALER DISPENSER/ADAPTER | Oct 9, 1990 | Substantially Equivalent |
| K900047 | THAYER SUCTION EVACUATION CONDENSATE COLLECTION | Apr 23, 1990 | Substantially Equivalent |