Philly Infant Bolt
FDA 510(k) K820151 · Philadelphia Medical Specialties
510(k) numberK820151
Submission
- Device name
- Philly Infant Bolt
- Applicant
- Philadelphia Medical Specialties
Walker, MI, US - Received
- January 19, 1982
- Decision date
- January 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Dizzydoctor Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K840999 | Philly Infant BoltGWM · Traditional | 04/04/1984SE |
| K834148 | Philly BoltsGWN · Traditional | 02/10/1984SE |
| K823459 | Philly Bolt Adult Procedure KitGWN · Traditional | 12/22/1982SE |
| K822636 | Class II Device for I.C.P. MonitoringGWM · Traditional | 09/14/1982SE |
| K813440 | Philly BoltGWM · Traditional | 12/18/1981SE |
Questions and answers
When was Philly Infant Bolt cleared by the FDA?
Philly Infant Bolt (K820151) received a 510(k) decision of Substantially Equivalent on January 28, 1982, 9 days after the submission was received.
What is the product code of K820151?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.