Philly Bolts
FDA 510(k) K834148 · Philadelphia Medical Specialties
510(k) numberK834148
Submission
- Device name
- Philly Bolts
- Applicant
- Philadelphia Medical Specialties
Mchenry, IL, US - Received
- November 16, 1983
- Decision date
- February 10, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K260566 | SMARTVERTIGO Vestibular Assessment SystemGWN · Traditional | VertigoDx, Inc. | 07/30/2026SE |
| K243709 | NeuroEars-AnnaGWN · Traditional | Neuroears, Inc. | 08/25/2025SE |
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| K203082 | Insight Infrared Video GogglesGWN · Traditional | Vestibular First | 11/12/2020SE |
| K200534 | VisualEyesGWN · Traditional | Interacoustics A/S | 08/12/2020SE |
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal…GWN · Traditional | Neurolign USA, LLC | 11/29/2019SE |
| K181771 | RightEye Vision SystemGWN · Traditional | Righteye, LLC | 09/28/2018SE |
| K182214 | DizzyDoctor System 1.0.0GWN · Traditional | Dizzydoctor Systems, LLC | 09/14/2018SE |
More from Dizzydoctor Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K840999 | Philly Infant BoltGWM · Traditional | 04/04/1984SE |
| K823459 | Philly Bolt Adult Procedure KitGWN · Traditional | 12/22/1982SE |
| K822636 | Class II Device for I.C.P. MonitoringGWM · Traditional | 09/14/1982SE |
| K820151 | Philly Infant BoltGWN · Traditional | 01/28/1982SE |
| K813440 | Philly BoltGWM · Traditional | 12/18/1981SE |
Questions and answers
When was Philly Bolts cleared by the FDA?
Philly Bolts (K834148) received a 510(k) decision of Substantially Equivalent on February 10, 1984, 86 days after the submission was received.
What is the product code of K834148?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.