MAXEMS, MODELS 1000 AND 2000— 510(k) K091248
Substantially EquivalentBio Protech, Inc.
FDA 510(k) clearance K091248 for MAXEMS, MODELS 1000 AND 2000, Substantially Equivalent on 2009-11-30. Applicant: Bio Protech, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio Protech, 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
- Dallas, TX, US
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