FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTEMPRO-MIST
K Number: K000543
·
Decision Jun 16, 2000
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
5
Review Days
119
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Basic Information
- Device Name
- CONTEMPRO-MIST
- K Number
- K000543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Contemporary Products, Inc.
- Date Received
- February 18, 2000
- Decision Date
- June 16, 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 Contemporary Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022865 | 6203 | Feb 13, 2003 | Substantially Equivalent |
| K992935 | OCD2001 | Jun 20, 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 |