FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BREMER IMAGING TONGS-MRI MODEL
K Number: K924606
·
Decision Sep 9, 1993
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
19
Applicant Total
2
Review Days
363
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Basic Information
- Device Name
- BREMER IMAGING TONGS-MRI MODEL
- K Number
- K924606
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5960
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bremer Medical, Inc.
- Date Received
- September 11, 1992
- Decision Date
- September 9, 1993
- Product Code
- HAX
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAX | Tong, Skull For Traction | FDA class 2 | Neurology |
Similar 510(k) Clearances
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FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
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Other Clearances by Bremer Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915800 | BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN | Mar 16, 1992 | Substantially Equivalent |