RM Electrode (RMH 25-01)
K-Number: K253586 · 2026-04-01
ApplicantRetmap, Inc.
Decision Date2026-04-01
Product CodeHLZ
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
RM Electrode (RMH 25-01) is a medical device manufactured by Retmap, Inc.. It received FDA 510(k) clearance on 2026-04-01 under approval number K253586. The device is classified under product code HLZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RM Electrode (RMH 25-01)?
RM Electrode (RMH 25-01) is a medical device that received FDA 510(k) clearance on 2026-04-01. It is manufactured by Retmap, Inc.. The 510(k) number is K253586.
When was RM Electrode (RMH 25-01) approved by the FDA?
RM Electrode (RMH 25-01) received FDA 510(k) clearance on 2026-04-01, under approval number K253586.
What company makes RM Electrode (RMH 25-01)?
RM Electrode (RMH 25-01) is manufactured by Retmap, Inc..
What is the FDA product code for RM Electrode (RMH 25-01)?
The FDA product code for RM Electrode (RMH 25-01) is HLZ.
Other Devices by Retmap, Inc.
Related Devices (Code: HLZ)
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.