FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
K Number: K042364
·
Decision Sep 30, 2004
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
- K Number
- K042364
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lamont Medical, Inc.
- Date Received
- August 31, 2004
- Decision Date
- September 30, 2004
- 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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Other Clearances by Lamont Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990522 | WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS | May 19, 1999 | Substantially Equivalent |