AXOSTIM NERVE STIMULATOR, MODIFICATION
FDA 510(k) clearance K905035 · decided 1991-04-19
Clearance details
- K-number
- K905035
- Device name
- AXOSTIM NERVE STIMULATOR, MODIFICATION
- Applicant
- Singer Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-25
- Decision date
- 1991-04-19
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Bensenville, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Singer Medical Products
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.