ACCLAIM
FDA 510(k) clearance K042266 · decided 2004-08-31
Clearance details
- K-number
- K042266
- Device name
- ACCLAIM
- Applicant
- Air Techniques, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-23
- Decision date
- 2004-08-31
- Days to decision
- 8 days
- Clearance type
- Special
- Product code
- NRD
- Device class
- 1
- Regulation number
- 872.6640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hicksville, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BELMONT QUOLIS 5000 SERIES DENTAL UNIT (K072273) | Takara Belmont USA, Inc. | 2007-12-20 |
Recalls involving this device
No recalls on record reference this clearance.