FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASYSTAND BANTAM MEDIUM
K Number: K123834
·
Decision Aug 13, 2013
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
52
Applicant Total
2
Review Days
243
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Basic Information
- Device Name
- EASYSTAND BANTAM MEDIUM
- K Number
- K123834
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3110
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Altimate Medical, Inc.
- Date Received
- December 13, 2012
- Decision Date
- August 13, 2013
- Product Code
- INO
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| INO | Chair, Positioning, Electric | FDA class 2 | Physical Medicine |
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Other Clearances by Altimate Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091242 | BANTAM | Jul 6, 2009 | Substantially Equivalent |