OBER2 Monitor, Eye Movement (Ophthalmic)
FDA 510(k) K902954 · Permobil AB
510(k) numberK902954
Submission
- Device name
- OBER2 Monitor, Eye Movement (Ophthalmic)
- Applicant
- Permobil AB
Burlington, MA, US - Received
- July 5, 1990
- Decision date
- August 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFC – Aspirator, Endocervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1050
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was OBER2 Monitor, Eye Movement (Ophthalmic) cleared by the FDA?
OBER2 Monitor, Eye Movement (Ophthalmic) (K902954) received a 510(k) decision of Substantially Equivalent on August 23, 1990, 49 days after the submission was received.
What is the product code of K902954?
The FDA product code is HFC – Aspirator, Endocervical, a Class II (moderate risk) device regulated under 21 CFR 884.1050.