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

Airport City Central, IL

NOVASIGHT appears in FDA device records in Airport City Central, IL. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. 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
1
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 1 510(k) clearance for Novasight in 2022.

Clearances by year, as a table
510(k) clearance decisions for Novasight, by decision year
YearClearances
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K221375CureSight-CS100QQUSubstantially Equivalent

Registered establishments

FDA registered establishments for Novasight, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30151688593015168859NOVASIGHT1 Negev St, Airport City Central 7019900 IL2026
30253969173025396917NOVASIGHT INC.16192 Costal Highway, Lewes, DE 19958 US2026No device listings on this registration

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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