FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
K Number: K003455
·
Decision Dec 6, 2000
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
70
Applicant Total
17
Review Days
29
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Basic Information
- Device Name
- MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
- K Number
- K003455
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chad Therapeutics, Inc.
- Date Received
- November 7, 2000
- Decision Date
- December 6, 2000
- Product Code
- NFB
- 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 |
|---|---|---|---|
| NFB | Conserver, Oxygen | FDA class 2 | Anesthesiology |
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Other Clearances by Chad Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081176 | FLOCHANNEL | Jul 28, 2008 | Substantially Equivalent |
| K070740 | CHAD THERAPEUTICS BONSAI MODEL 800 | May 7, 2007 | Substantially Equivalent |
| K042142 | CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S | Sep 20, 2004 | Substantially Equivalent |
| K033364 | CHAD THERAPEUTICS SAGE | May 11, 2004 | Substantially Equivalent |
| K020475 | CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 | Jul 5, 2002 | Substantially Equivalent |
| K013472 | TOTAL O2 | Nov 28, 2001 | Substantially Equivalent |
| K010389 | CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 | Mar 23, 2001 | Substantially Equivalent |
| K000890 | CHAD THERAPEUTICS OXYMATIC MODEL 401 | Jun 16, 2000 | Substantially Equivalent |
| K971889 | CHAD TOTAL O2 DELIVERY SYSTEM | Nov 17, 1997 | Substantially Equivalent |
| K884562 | OXYMATIC-24 | Jan 9, 1989 | Substantially Equivalent |