Cca-200
by Benson Medical Instruments Co.
510(k) K981439
Cca-200 is a medical device (FDA Class II; FDA product code EWO, Audiometer) made by Benson Medical Instruments Co., cleared under FDA 510(k) K981439 on 15 Jun 1998, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981439 | Date15 Jun 1998 | StatusActive |
Official records
- FDA 510(k) database K981439
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EWO
- Device class
- Class II
- Regulation
- 21 CFR Part 874.1050
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
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