Nautilus
FDA 510(k) clearance K220871 · decided 2022-04-18
Clearance details
- K-number
- K220871
- Device name
- Nautilus
- Applicant
- Dornier Medtech America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-25
- Decision date
- 2022-04-18
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kennesaw, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DORNIER EPOS ULTRA (P000048) | Dornier Medtech America, Inc. | 2002-01-15 |
| DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE (P840008/S069) | Dornier Medtech America, Inc. | 1999-09-02 |
| DORNIER LITHOTRIPTER-DOLI S AND COMPACT DELTA (P840008/S067) | Dornier Medtech America, Inc. | 1999-03-12 |
| UROWAVE (P970044/S003) | Dornier Medtech America, Inc. | 1999-03-12 |
| DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE/TRANSPORTABLE (P840008/S068) | Dornier Medtech America, Inc. | 1999-02-26 |
| DORNIER COMPACT DELTA LITHOTRIPTER (P840008/S066) | Dornier Medtech America, Inc. | 1998-08-21 |
| DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM (P970044/S002) | Dornier Medtech America, Inc. | 1998-07-10 |
| DORNIER COMPACT DELTA (P840008/S065) | Dornier Medtech America, Inc. | 1998-07-07 |