ALGO I
FDA 510(k) clearance K852687 · decided 1985-09-18
Clearance details
- K-number
- K852687
- Device name
- ALGO I
- Applicant
- Algotek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-25
- Decision date
- 1985-09-18
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- GWJ
- Device class
- 2
- Regulation number
- 882.1900
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| QScreen (K220139) | Path Medical GmbH | 2022-08-03 |
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| SmartEP (K163326) | Intelligent Hearing Systems | 2017-09-29 |
| Eclipse with VEMP (K162037) | Interacoustics A/S | 2017-03-23 |
| ICS CHARTR EP 200 WITH VEMP (K143670) | Gn Otometrics A/S | 2015-10-23 |
| ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, (K141446) | Natus Medical Incorporated | 2014-08-22 |
| MADSEN ACCUSCREEN TYPE 1077 (K132957) | Gn Otometrics | 2014-02-27 |
| EARPROBE (K131141) | Path Medical GmbH | 2013-06-27 |
| HEARLAB ACA (K123701) | Frye Electronics, Inc. | 2013-04-05 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screene recall (Z-0985-05) | Natus Medical Inc | 2005-07-13 |