UPPER BODY CYCLES (110 VOLT)/(220 VOLT)— 510(k) K935520
Substantially EquivalentBiodex Medical Systems, Inc.
FDA 510(k) clearance K935520 for UPPER BODY CYCLES (110 VOLT)/(220 VOLT), Substantially Equivalent on 1994-09-16. Applicant: Biodex Medical Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Biodex Medical Systems, Inc.
- Product code
- Code BXB
- Device class
- Class 1
- Regulation
- 21 CFR 890.5380
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shirley, NY, US
Recent devices under product code BXB
view allMore clearances from Biodex Medical Systems, Inc.
view all- K090296 — ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
- K063666 — SHARPS CONTAINER, MODEL 039-413
- K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
- K950981 — ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650
- K942694 — STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302
Data sourced from openFDA. This site is unofficial and independent of the FDA.