FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AM-PAK
K Number: K912436
·
Decision Oct 18, 1991
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
14
Review Days
137
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Basic Information
- Device Name
- AM-PAK
- K Number
- K912436
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1835
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cns, Inc.
- Date Received
- June 3, 1991
- Decision Date
- October 18, 1991
- Product Code
- GWL
- 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 |
|---|---|---|---|
| GWL | Amplifier, Physiological Signal | FDA class 2 | Neurology |
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Other Clearances by Cns, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955711 | BREATHE RIGHT NASAL STRIP | May 30, 1996 | Substantially Equivalent |
| K954914 | BREATHE RIGHT NASAL STRIP | Feb 27, 1996 | Substantially Equivalent |
| K953772 | BREATHE RIGHT NASAL STRIP | Oct 20, 1995 | Substantially Equivalent |
| K950273 | SLEEP TEST(TM) | Sep 19, 1995 | Substantially Equivalent |
| K921220 | BREATHE RIGHT | Oct 7, 1993 | Substantially Equivalent |
| K904432 | SLEEP I/T-5 AND SLEEP I/T-8 | Jul 10, 1991 | Substantially Equivalent |
| K910452 | RESPI-PAK RT-PAK | Apr 16, 1991 | Substantially Equivalent |
| K901549 | CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE. | Oct 24, 1990 | Substantially Equivalent |
| K897107 | POLY G PHYSIOLOGICAL DATA RECORDER | Mar 12, 1990 | Substantially Equivalent |
| K860829 | CNS 4/8 AND CT 48.1 SOFTWARE | May 29, 1986 | Substantially Equivalent |