510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bodystat Ltd

Isle of Man, IM

BODYSTAT LTD appears in FDA device records in Isle of Man, IM. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 8 510(k) clearances for Bodystat Ltd between 1995 and 2011. The busiest year on record is 2011, with 2. The most recent is 2011, with 2.

Clearances by year, as a table
510(k) clearance decisions for Bodystat Ltd, by decision year
YearClearances
19951
19971
19981
20001
20011
20081
20112
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K082255QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNITMNWSubstantially Equivalent
K082254MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNITMNWSubstantially Equivalent
K082253BODYSTAT 1500 BODY COMPOSITION MONITORING UNITMNWSubstantially Equivalent
K002835BODYSTATMNWSubstantially Equivalent
K994242BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNITMNWSubstantially Equivalent
K980971BODYSTAT DUALSCAN 2005MNWSubstantially Equivalent
K971554BODYSTATMNWSubstantially Equivalent
K951097BODYSTAYDSBSubstantially Equivalent

Registered establishments

FDA registered establishments for Bodystat Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30069482173006948217BODYSTAT LTDChester House, Main Road, Isle of Man IM7 2HJ IM2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain