FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLEEP TEST(TM)
K Number: K950273
·
Decision Sep 19, 1995
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
14
Review Days
239
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Basic Information
- Device Name
- SLEEP TEST(TM)
- K Number
- K950273
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cns, Inc.
- Date Received
- January 23, 1995
- Decision Date
- September 19, 1995
- Product Code
- MNR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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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 |
| K921220 | BREATHE RIGHT | Oct 7, 1993 | Substantially Equivalent |
| K912436 | AM-PAK | Oct 18, 1991 | 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 |