ELITE— 510(k) K810246
Substantially EquivalentBloomex International, Inc.
FDA 510(k) clearance K810246 for ELITE, Substantially Equivalent on 1981-03-16. Applicant: Bloomex International, Inc.. Device class: 2.
Clearance details
- Applicant
- Bloomex International, Inc.
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code IPF
view allMore clearances from Bloomex International, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.