Ophthascan Mini-B
FDA 510(k) K884595 · Biophysic Medical, Inc.
510(k) numberK884595
Submission
- Device name
- Ophthascan Mini-B
- Applicant
- Biophysic Medical, Inc.
Pleasant Hill, CA, US - Received
- November 3, 1988
- Decision date
- January 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|
| K953399 | Needle or CutterKNW · Traditional | 10/30/1995SE |
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| K890509 | Indirect Ophthalmoscope Accessory Delivery SystemHQF · Traditional | 03/24/1989SE |
| K884456 | Sterile Disposable Endocular ProbeGEX · Traditional | 12/09/1988SE |
| K883719 | Interconn. of Ophthalas & Nanolas Laser SystemLQJ · Traditional | 10/18/1988SE |
| K881494 | Four Modifications to Ophthalas Argon/Dye LaserHQF · Traditional | 08/30/1988SN |
| K881459 | Nanolas Nd:Yag Ophthalmic LaserLOI · Traditional | 04/13/1988SE |
| K873460 | Ophthalas Dye Ophthalmic LaserHQF · Traditional | 10/29/1987SE |
| K853116 | PaxialIYO · Traditional | 10/31/1985SE |
| K844686 | Ophthascan BIYO · Traditional | 09/13/1985SE |
Questions and answers
When was Ophthascan Mini-B cleared by the FDA?
Ophthascan Mini-B (K884595) received a 510(k) decision of Substantially Equivalent on January 3, 1989, 61 days after the submission was received.
What is the product code of K884595?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.