Bio-Pen Calculator
FDA 510(k) K860205 · Oculab, Inc.
510(k) numberK860205
Submission
- Device name
- Bio-Pen Calculator
- Applicant
- Oculab, Inc.
Gendale, CA, US - Received
- January 22, 1986
- Decision date
- April 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQB – Medical Computers And Software For Ophthalmic Use
- Device class
- Class III (high risk)
Other 510(k)s with product code LQB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922590 | Bio-Pen SRK II CalculatorLQB · Traditional | Bio-Rad | 08/03/1993SE |
More from Bio-Rad
| 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 |
| K860062 | Oculab PachpenIYO · Traditional | 03/10/1986SE |
| K860061 | Oculab BiometricpenIYO · Traditional | 03/10/1986SE |
| K852774 | Oculab TonopenHKY · Traditional | 08/20/1985SE |
Questions and answers
When was Bio-Pen Calculator cleared by the FDA?
Bio-Pen Calculator (K860205) received a 510(k) decision of Substantially Equivalent on April 24, 1986, 92 days after the submission was received.
What is the product code of K860205?
The FDA product code is LQB – Medical Computers And Software For Ophthalmic Use, a Class III (high risk) device.