FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GALILEO HALLEY
K Number: K970703
·
Decision May 19, 1997
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
20
Review Days
82
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Basic Information
- Device Name
- GALILEO HALLEY
- K Number
- K970703
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosound Esaote, Inc.
- Date Received
- February 26, 1997
- Decision Date
- May 19, 1997
- Product Code
- GWQ
- 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 |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | FDA class 2 | Neurology |
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Other Clearances by Biosound Esaote, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023255 | TECHNOS MP, MODEL AU6 | Feb 11, 2003 | Substantially Equivalent |
| K014168 | AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) | Apr 25, 2002 | Substantially Equivalent |
| K020164 | E-SCAN XQ | Feb 12, 2002 | Substantially Equivalent |
| K012728 | E-SCAN MRI SYSTEM | Aug 29, 2001 | Substantially Equivalent |
| K010405 | 7230 ULTRASOUND IMAGING SYSTEM WITH TEI | Mar 13, 2001 | Substantially Equivalent |
| K010057 | MODIFICATION TO ARTOSCAN M | Feb 2, 2001 | Substantially Equivalent |
| K001894 | MODIFICATION TO E-SCAN | Jul 6, 2000 | Substantially Equivalent |
| K000931 | AU5 ULTRASOUND IMAGING SYSTEM | Jun 8, 2000 | Substantially Equivalent |
| K000681 | AU5, AU6 | May 3, 2000 | Substantially Equivalent |
| K994369 | 7250 (MEGAS) | Feb 24, 2000 | Substantially Equivalent |