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Treatment Unit For Doctor's Rounds
FDA 510(k)Class I (US FDA 510(k))
510(k) K801740
Identifiers
- 510(k) Number
- K801740 FDA 510(k)
- FDA Product Code
- ETF FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.5300 FDA 510(k)
- Regulation Number
- 874.5300 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TREATMENT UNIT FOR DOCTOR'S ROUNDS, a traditional medical device, was granted substantially equivalent clearance from EN advisory committee and has undergone expedited review. Developed by Jedmed Instrument Co., this unit is designed for ENT examination and treatment in clinics and hospitals.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K801740 | Class I | Active |
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Manufacturer
- Manufacturer
- Jedmed Instrument Co.
Sources (1)
- FDA 510(k) K801740 24 fields · synced Jul 21, 2026