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510(k) K071977

TARRY MEDICAL TEMPERATURE PROBES by Tarry Medical Products, Inc. — Product Code FMZ

K071977 is an FDA 510(k) premarket notification submitted by Tarry Medical Products, Inc. for the device "TARRY MEDICAL TEMPERATURE PROBES". The FDA issued a decision of Substantially Equivalent on May 23, 2008. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2008
Date Received
July 17, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type

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  • K243437 — mOm Essential Incubator (ME1) (August 14, 2025)
  • K213553 — Giraffe Incubator Carestation CS1 (March 2, 2022)
  • K190494 — Infant Incubator (November 25, 2019)
  • K182859 — Babyleo TN500 (February 22, 2019)
  • K182977 — Isolette 8000 Plus (November 21, 2018)
  • K172154 — Isolette 8000 plus (April 19, 2018)
  • K162821 — Babyleo TN500 (June 23, 2017)
  • K152814 — Giraffe OmniBed Carestation CS1 (March 17, 2016)

FDA data resources