ThermoShield HME Filter
510(k) K163300
ThermoShield HME Filter is a Class II device made by Flexicare Medical Limited, cleared under FDA 510(k) K163300 on 22 Mar 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163300 | Date22 Mar 2017 | StatusActive |
Official records
- FDA 510(k) database K163300
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CAH
- FDA applicant
- Flexicare Medical Limited.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5260
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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