FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARPAC MESSENGER MODEL #501
K Number: K041485
·
Decision Aug 2, 2004
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
108
Applicant Total
3
Review Days
59
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Basic Information
- Device Name
- MARPAC MESSENGER MODEL #501
- K Number
- K041485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Marpac, Inc.
- Date Received
- June 4, 2004
- Decision Date
- August 2, 2004
- Product Code
- JOH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | FDA class 2 | Anesthesiology |
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