FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCD2001
K Number: K992935
·
Decision Jun 20, 2000
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
70
Applicant Total
5
Review Days
294
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Basic Information
- Device Name
- OCD2001
- K Number
- K992935
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Contemporary Products, Inc.
- Date Received
- August 31, 1999
- Decision Date
- June 20, 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 Contemporary Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022865 | 6203 | Feb 13, 2003 | Substantially Equivalent |
| K000543 | CONTEMPRO-MIST | Jun 16, 2000 | Substantially Equivalent |
| K964994 | CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR | Feb 21, 1997 | Substantially Equivalent |
| K963558 | CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR | Dec 4, 1996 | Substantially Equivalent |