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

Golden, CO, US

Nicolet Biomedical, Inc. appears in FDA device records in Golden, CO. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
18
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 18 510(k) clearances for Nicolet Biomedical, Inc. between 1995 and 2003. The busiest year on record is 2001, with 6. The most recent is 2003, with 1.

Clearances by year, as a table
510(k) clearance decisions for Nicolet Biomedical, Inc., by decision year
YearClearances
19951
19971
19981
19991
20002
20016
20025
20031
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K020754NICOLET PIONEER TC8080IYNSubstantially Equivalent
K021986BRAINETGXYSubstantially Equivalent
K021144SUBDURAL STRIP ELECTRODEGYCSubstantially Equivalent
K020218SNAP EEG MONITOROLWSubstantially Equivalent
K013281VERSALAB APMHGMSubstantially Equivalent
K020955NICOLET ELECTROCAUTERY DETECTORETNSubstantially Equivalent
K013419NICOLET ELECTROMAGNETIC NAVIGATION SYSTEMLLZSubstantially Equivalent
K011823BIOREHAB SYSTEMHCCSubstantially Equivalent
K011818STERILE EMG ELECTRODESIKTSubstantially Equivalent
K011135GSI AUDERAEWOSubstantially Equivalent
K010019STERILE SUBDERMAL NEEDLE ELECTRODESGXZSubstantially Equivalent
K010521NICOLET VERSALABJAFSubstantially Equivalent
K002766NICOLET VASOGUARDJOPSubstantially Equivalent
K993939NICOLET EME LEGEND TC22IYNSubstantially Equivalent
K991054BRAVO MULTI-MODALITY SYSTEMGWQSubstantially Equivalent
K982635CAREDOP IIJAFSubstantially Equivalent
K971331SATELLITEGWQSubstantially Equivalent
K950270NMI SOFTWAREOMBSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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