FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIGHTRON POLYSOMNOGRAPHY SYSTEM
K Number: K022249
·
Decision Dec 31, 2002
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
14
Review Days
172
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Basic Information
- Device Name
- NIGHTRON POLYSOMNOGRAPHY SYSTEM
- K Number
- K022249
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Telediagnostic Systems, Inc.
- Date Received
- July 12, 2002
- Decision Date
- December 31, 2002
- 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 Telediagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071661 | ALPHAONE BIOFEEDBACK SYSTEM | Sep 5, 2007 | Substantially Equivalent |
| K970659 | DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER | May 16, 1997 | Substantially Equivalent |
| K904328 | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM | Jun 18, 1991 | Substantially Equivalent |
| K904222 | VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER | Jan 18, 1991 | Substantially Equivalent |
| K885328 | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER | Mar 22, 1989 | Substantially Equivalent |
| K884891 | OC-100 OXIMETER INTERFACE CALIBRATOR | Dec 28, 1988 | Substantially Equivalent |
| K883947 | ISO-100 ISOLATION AMPLIFIER | Dec 5, 1988 | Substantially Equivalent |
| K874257 | S-10 TELEPHONIC POLYSOMNOGRAPH | Dec 11, 1987 | Substantially Equivalent |
| K871120 | M10 EEG MONITOR SCOPE | May 1, 1987 | Substantially Equivalent |
| K810872 | EEG TELEPHONE RECEIVER MODEL #AFR-J | May 1, 1981 | Substantially Equivalent |