Kolposkop KP20005
by Elmed, Inc.
510(k) K791279
Kolposkop KP20005 is a medical device (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Elmed, Inc., cleared under FDA 510(k) K791279 on 17 Sep 1979, active as of 11 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 | NumberK791279 | Date17 Sep 1979 | StatusActive |
Official records
- FDA 510(k) database K791279
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HEX
- Device class
- Class II
- Regulation
- 21 CFR Part 884.1630
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
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