ThermoShield HME Filter
FDA 510(k) clearance K163300 · decided 2017-03-22
Clearance details
- K-number
- K163300
- Device name
- ThermoShield HME Filter
- Applicant
- Flexicare Medical Limited.
- Decision
- Substantially Equivalent
- Date received
- 2016-11-22
- Decision date
- 2017-03-22
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mountain Ash, GB
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Flexicare Medical Limited.
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.