NOVA BALLOON THERMODILUTION CATH.
FDA 510(k) clearance K841639 · decided 1984-08-12
Clearance details
- K-number
- K841639
- Device name
- NOVA BALLOON THERMODILUTION CATH.
- Applicant
- Nova Medical Specialties
- Decision
- Substantially Equivalent
- Date received
- 1984-04-20
- Decision date
- 1984-08-12
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- DYG
- Device class
- 2
- Regulation number
- 870.1240
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nova Medical Specialties
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.