Digilab Cambridge Perimeter
FDA 510(k) K860115 · Bio-Rad
510(k) numberK860115
Submission
- Device name
- Digilab Cambridge Perimeter
- Applicant
- Bio-Rad
Beverly, MA, US - Received
- January 13, 1986
- Decision date
- February 27, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOO – Perimeter, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1605
- Specialty
- Ophthalmic
Other 510(k)s with product code HOO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941723 | Welch Allyn Glaucoma DetectorHOO · Traditional | Welch Allyn, Inc. | 06/06/1994SE |
| K930448 | Marco Projection PerimeterHOO · Traditional | Marco Ophthalmic, Inc. | 06/21/1993SE |
| K873912 | Richmond Visual Field ScreenerHOO · Traditional | Richmond Products, Inc. | 11/02/1987SE |
| K864467 | Henson - Hamblin CFS 2000 Central Field ScreenHOO · Traditional | Keeler Instruments, Inc. | 12/15/1986SE |
| K832800 | Automatic Tangent Screen 50HOO · Traditional | CooperVision, Inc. | 09/29/1983SE |
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Questions and answers
When was Digilab Cambridge Perimeter cleared by the FDA?
Digilab Cambridge Perimeter (K860115) received a 510(k) decision of Substantially Equivalent on February 27, 1986, 45 days after the submission was received.
What is the product code of K860115?
The FDA product code is HOO – Perimeter, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1605.