FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALGO 5 NEWBORN HEARING SCREENER
K Number: K073665
·
Decision Jan 25, 2008
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
12
Review Days
30
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Basic Information
- Device Name
- ALGO 5 NEWBORN HEARING SCREENER
- K Number
- K073665
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Natus Medical, Inc.
- Date Received
- December 26, 2007
- Decision Date
- January 25, 2008
- Product Code
- GWJ
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | FDA class 2 | Neurology |
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| K051869 | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM | Oct 7, 2005 | Substantially Equivalent |
| K030823 | ALGO 3I NEWBORN HEARING SCREENER | Apr 9, 2003 | Substantially Equivalent |
| K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT | Sep 19, 2002 | Substantially Equivalent |
| K013137 | ALGO 3 NEWBORN HEARING SCREENER | Oct 16, 2001 | Substantially Equivalent |
| K974805 | CO-STAT(TM) END TIDAL BREATH ANALYZER | Mar 11, 1998 | Substantially Equivalent |
| K935160 | MINIMUFFS | Feb 9, 1995 | Substantially Equivalent |