FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RC CORNET, MODEL #44F50
K Number: K983308
·
Decision Jun 4, 1999
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
8
Review Days
256
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Basic Information
- Device Name
- RC CORNET, MODEL #44F50
- K Number
- K983308
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pari Holding Co.
- Date Received
- September 21, 1998
- Decision Date
- June 4, 1999
- Product Code
- BWF
- 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | FDA class 2 | Anesthesiology |
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|---|---|---|---|
| K002862 | PRONEB ULTRA MODEL NUMBER 85B0100 | Mar 13, 2001 | Substantially Equivalent |
| K972042 | PARI PEP THERAPY SYSTEM | Aug 5, 1997 | Substantially Equivalent |
| K963924 | LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 | Dec 10, 1996 | Substantially Equivalent |
| K962072 | PRONEB TURBO COMPRESSOR MODEL 38V0200 | Aug 21, 1996 | Substantially Equivalent |
| K960675 | WALKHALER PORTABLE COMPRESSOR MODEL 45F70 | May 17, 1996 | Substantially Equivalent |
| K935540 | PARI-MASTER MODIFICATION | Mar 17, 1995 | Substantially Equivalent |
| K944152 | PARI BABY | Nov 18, 1994 | Substantially Equivalent |