FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIRIT 300
K Number: K013251
·
Decision Dec 18, 2001
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
54
Applicant Total
5
Review Days
81
Basic Information
- Device Name
- SPIRIT 300
- K Number
- K013251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5655
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CAIRE, INC.
- Date Received
- September 28, 2001
- Decision Date
- December 18, 2001
- Product Code
- BYJ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BYJ | Unit, Liquid-Oxygen, Portable | FDA class 2 | Anesthesiology |
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Other Clearances by CAIRE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K120785 | OMNI 3 OXYGEN SYSTEM | Oct 25, 2012 | Substantially Equivalent |
| K080023 | MODIFICATION TO: SPIRIT | Jun 16, 2008 | Substantially Equivalent |
| K050153 | SPIRIT, MODEL HAS | Apr 15, 2005 | Substantially Equivalent |
| K952268 | MODEL DELTA, OM OXYGEN CONCENTRATOR | Aug 11, 1995 | Substantially Equivalent |