FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
H20- TETHERED OPTION
K Number: K992291
·
Decision Aug 6, 1999
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
12
Review Days
30
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Basic Information
- Device Name
- H20- TETHERED OPTION
- K Number
- K992291
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Grass-Telefactor Product Group
- Date Received
- July 7, 1999
- Decision Date
- August 6, 1999
- 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 Grass-Telefactor Product Group
| K Number | Device Name | ||
|---|---|---|---|
| K974583 | DEEGLITE | Jun 9, 1998 | Substantially Equivalent |
| K974587 | H2O | Mar 9, 1998 | Substantially Equivalent |
| K972202 | DEEG-LITE | Jul 23, 1997 | Substantially Equivalent |
| K925838 | TELEFACTOR D/EEG-32 | Apr 30, 1993 | Substantially Equivalent |
| K884937 | BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING | Apr 14, 1989 | Substantially Equivalent |
| K870432 | A1-A2 AMBULATORY EEG CASSETTE RECORDER | May 8, 1987 | Substantially Equivalent |
| K871480 | STD-228 SPECTRAL TREND DISPLAY | May 1, 1987 | Substantially Equivalent |
| K870450 | SZAC-16 SEIZURE ANALYSIS COMPUTER | Apr 8, 1987 | Substantially Equivalent |
| K870381 | DD-VCR-64 | Mar 25, 1987 | Substantially Equivalent |
| K860219 | SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM | Apr 17, 1986 | Substantially Equivalent |