Monotime and Optime R
K-Number: K233265 · 2024-10-11
ApplicantPeters Surgical
Decision Date2024-10-11
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Monotime and Optime R is a medical device manufactured by Peters Surgical. It received FDA 510(k) clearance on 2024-10-11 under approval number K233265. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Monotime and Optime R?
Monotime and Optime R is a medical device that received FDA 510(k) clearance on 2024-10-11. It is manufactured by Peters Surgical. The 510(k) number is K233265.
When was Monotime and Optime R approved by the FDA?
Monotime and Optime R received FDA 510(k) clearance on 2024-10-11, under approval number K233265.
What company makes Monotime and Optime R?
Monotime and Optime R is manufactured by Peters Surgical.
What is the FDA product code for Monotime and Optime R?
The FDA product code for Monotime and Optime R is GAM.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.