3M FILTRETE(TM) AIR FILTER MEDIA
FDA 510(k) clearance K946225 · decided 1995-05-25
Clearance details
- K-number
- K946225
- Device name
- 3M FILTRETE(TM) AIR FILTER MEDIA
- Applicant
- Tagg Industries
- Decision
- Substantially Equivalent
- Date received
- 1994-12-12
- Decision date
- 1995-05-25
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- CBP
- Device class
- 2
- Regulation number
- 868.5870
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Laguna Hills, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tagg Industries
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.