FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MOVES
K Number: K093261
·
Decision Mar 26, 2010
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
5
Review Days
158
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Basic Information
- Device Name
- MOVES
- K Number
- K093261
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thornhill Research, Inc.
- Date Received
- October 19, 2009
- Decision Date
- March 26, 2010
- Product Code
- BTL
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Expedited Review
- Y
- 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 |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | FDA class 2 | Anesthesiology |
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