FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMBLA
K Number: K971813
·
Decision Jan 16, 1998
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
57
Review Days
245
Basic Information
- Device Name
- EMBLA
- K Number
- K971813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ferguson Medical
- Date Received
- May 16, 1997
- Decision Date
- January 16, 1998
- Product Code
- OLV
- 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 |
|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | FDA class 2 | Neurology |
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| K970257 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES | May 22, 1997 | Substantially Equivalent |
| K960421 | SINUSCAN 102/SINUSPRINT | Apr 16, 1997 | Substantially Equivalent |