Grass-Telefactor Product Group
W. Conshohocken, PA, US
Grass-Telefactor Product Group appears in FDA device records in W. Conshohocken, PA. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Grass-Telefactor Product Group between 1986 and 1999. The busiest year on record is 1987, with 4. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1987 | 4 |
| 1989 | 1 |
| 1993 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992291 | H20- TETHERED OPTION | OLV | Substantially Equivalent | |
| K974583 | DEEGLITE | OLV | Substantially Equivalent | |
| K974587 | H2O | OLV | Substantially Equivalent | |
| K972202 | DEEG-LITE | GWQ | Substantially Equivalent | |
| K925838 | TELEFACTOR D/EEG-32 | GWQ | Substantially Equivalent | |
| K884937 | BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING | EEG | Substantially Equivalent | |
| K870432 | A1-A2 AMBULATORY EEG CASSETTE RECORDER | GWQ | Substantially Equivalent | |
| K871480 | STD-228 SPECTRAL TREND DISPLAY | GWS | Substantially Equivalent | |
| K870450 | SZAC-16 SEIZURE ANALYSIS COMPUTER | OMB | Substantially Equivalent | |
| K870381 | DD-VCR-64 | GWK | Substantially Equivalent | |
| K860219 | SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM | OLV | Substantially Equivalent | |
| K860128 | MODAC-XXXX INTENSIVE MONITORING OF EEG | GYE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GWSAnalyzer, Spectrum, Electroencephalogram Signal
- OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph
- GWKConditioner, Signal, Physiological
- GYEEncephalogram Telemetry System
- GWQFull-Montage Standard Electroencephalograph
- EEGHeat Source For Bleaching Teeth
- OLVStandard Polysomnograph With Electroencephalograph
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain