510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K837102Substantially Equivalent

Model 2100 Fetal Monitor

Huntleigh Group, Ltd., Luton Beds Lu1 1uu, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837102 is the FDA 510(k) clearance record for MODEL 2100 FETAL MONITOR, cleared for Huntleigh Group , Ltd. on . FDA records list one 510(k) clearance for Huntleigh Group , Ltd. As of , FDA records show no recalls naming K837102.

Clearance record

Decision date
Received
(66 days to decision)
Review panel
Unknown
Applicant
Huntleigh Group , Ltd. 310-312 Dallow Rd., Luton Beds Lu1 1uu, GB
Third party review
No