ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336— 510(k) K090296
Substantially EquivalentBiodex Medical Systems, Inc.
FDA 510(k) clearance K090296 for ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336, Substantially Equivalent on 2009-02-19. Applicant: Biodex Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Biodex Medical Systems, Inc.
- Product code
- Code KPT
- Device class
- Class 2
- Regulation
- 21 CFR 892.1360
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shirley, NY, US
Recent devices under product code KPT
view allMore clearances from Biodex Medical Systems, Inc.
view allRecalls naming K090296
K-number listed on FDA's recall record- Z-2580-2021 — Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
- Z-2581-2021 — AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090296.
Data sourced from openFDA. This site is unofficial and independent of the FDA.