NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING
FDA 510(k) clearance K822269 · decided 1982-09-09
Clearance details
- K-number
- K822269
- Device name
- NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING
- Applicant
- Kelleher Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-29
- Decision date
- 1982-09-09
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- EWC
- Device class
- 1
- Regulation number
- 874.1060
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kelleher Corp.
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.
| Record | Firm | Date |
|---|---|---|
| EMERGENCY TRACHEOSTOMY KIT (K823872) | Omnicon Medical Corp. | 1983-01-21 |
Recalls involving this device
No recalls on record reference this clearance.