HYDROPULSE(GROSSAN);INFLAT TUBE MASS
FDA 510(k) clearance K834507 · decided 1984-01-17
Clearance details
- K-number
- K834507
- Device name
- HYDROPULSE(GROSSAN);INFLAT TUBE MASS
- Applicant
- Amrex-Zetron, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-21
- Decision date
- 1984-01-17
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Amrex-Zetron
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.
Recalls involving this device
No recalls on record reference this clearance.