5011 Ganzfeld Stimulator
FDA 510(k) K822922 · Life-Tech Intl., Inc.
510(k) numberK822922
Submission
- Device name
- 5011 Ganzfeld Stimulator
- Applicant
- Life-Tech Intl., Inc.
Mchenry, IL, US - Received
- October 1, 1982
- Decision date
- December 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HLX – Photostimulator, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1630
- Specialty
- Ophthalmic
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| K873990 | Iras Eds Interferometric StimulatorHLX · Traditional | Randwal Instrument Co., Inc. | 02/05/1988SE |
| K853812 | Photron Neurovisual Stimulator(Modification)HLX · Traditional | Biosan Laboratories, Inc. | 11/01/1985SE |
| K833446 | Downing Spectral IlluminatorHLX · Traditional | Vision Health Technology | 03/12/1984SE |
| K832762 | Miller/Nadler Glare TesterHLX · Traditional | Titmus Optical, Inc. | 09/29/1983SE |
| K831231 | LED GogglesHLX · Traditional | Cadwell Laboratories, Inc. | 05/16/1983SE |
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| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
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Questions and answers
When was 5011 Ganzfeld Stimulator cleared by the FDA?
5011 Ganzfeld Stimulator (K822922) received a 510(k) decision of Substantially Equivalent on December 28, 1982, 88 days after the submission was received.
What is the product code of K822922?
The FDA product code is HLX – Photostimulator, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1630.