FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER
K Number: K904222
·
Decision Jan 18, 1991
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
14
Review Days
127
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Basic Information
- Device Name
- VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER
- K Number
- K904222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1835
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Telediagnostic Systems, Inc.
- Date Received
- September 13, 1990
- Decision Date
- January 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 Telediagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071661 | ALPHAONE BIOFEEDBACK SYSTEM | Sep 5, 2007 | Substantially Equivalent |
| K022249 | NIGHTRON POLYSOMNOGRAPHY SYSTEM | Dec 31, 2002 | 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 |
| 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 |