Oculab Pachpen
FDA 510(k) K860062 · Oculab, Inc.
510(k) numberK860062
Submission
- Device name
- Oculab Pachpen
- Applicant
- Oculab, Inc.
Glendale, CA, US - Received
- January 6, 1986
- Decision date
- March 10, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K884619 | Pach-Pen CalculatorDXG · Traditional | 02/02/1989SE |
| K882750 | Ocu-Film Tip CoverHKY · Traditional | 08/04/1988SE |
| K862016 | Pach-Pen Surgical DrapeKKX · Traditional | 06/04/1986SE |
| K860205 | Bio-Pen CalculatorLQB · Traditional | 04/24/1986SE |
| K860061 | Oculab BiometricpenIYO · Traditional | 03/10/1986SE |
| K852774 | Oculab TonopenHKY · Traditional | 08/20/1985SE |
Questions and answers
When was Oculab Pachpen cleared by the FDA?
Oculab Pachpen (K860062) received a 510(k) decision of Substantially Equivalent on March 10, 1986, 63 days after the submission was received.
What is the product code of K860062?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.