Atlas FDA

MODIFICATION TO THERMAL ANGEL

FDA 510(k) clearance K012031 · decided 2001-07-26

Clearance details

K-number
K012031
Device name
MODIFICATION TO THERMAL ANGEL
Applicant
Estill Medical Technologies, Inc.
Decision
Substantially Equivalent
Date received
2001-06-28
Decision date
2001-07-26
Days to decision
28 days
Clearance type
Special
Product code
BSB
Device class
2
Regulation number
864.9205
Medical specialty
Hematology
Advisory committee
Hematology
Location
Dallas, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rech recall (Z-0101-2015)Estill Medical Technologies, Inc2014-10-21