FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
K Number: K001013
·
Decision May 16, 2000
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
18
Review Days
48
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Basic Information
- Device Name
- MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
- K Number
- K001013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Airsep Corp.
- Date Received
- March 29, 2000
- Decision Date
- May 16, 2000
- 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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| K000963 | DA VINCHI EEG AND EMG/EP SYSTEMS | Oct 20, 2000 | Substantially Equivalent |
| K001579 | IMPULSE SELECT | Aug 31, 2000 | Substantially Equivalent |
| K001467 | DA VINCHI EMG/EP ISA1004EP | Aug 1, 2000 | Substantially Equivalent |
| K992283 | ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY | Aug 27, 1999 | Substantially Equivalent |
| K983002 | MYSTIQUE ULTRASONIC NEBULIZER | Oct 16, 1998 | Substantially Equivalent |
| K960309 | AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) | Feb 28, 1997 | Substantially Equivalent |