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510(k) K821896

C-300 INFANT INCUBATOR by Narco Scientific — Product Code FMZ

K821896 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "C-300 INFANT INCUBATOR". The FDA issued a decision of Substantially Equivalent on July 28, 1982. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Narco Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1982
Date Received
June 28, 1982
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

Other clearances by Narco Scientific

  • K830338 — NARCOTRACE 80 (December 22, 1983)
  • K831429 — AS 191 ECG TELEMETRY MODULE (October 14, 1983)
  • K831428 — AS 1740 INTERFACE MODULE (October 14, 1983)
  • K822835 — PZ-800 VOLUME VENTILATOR (September 29, 1983)
  • K831430 — AIR SHIELDS AS-100 MONIORING SYS-AS105 (September 12, 1983)
  • K831460 — AS 30/TCP MODULE (July 12, 1983)
  • K830123 — DISP. YANKAVER SURG. SUCTION INSTRUMENT (June 8, 1983)
  • K831028 — TI-1000 TRANSPORT INCUBATOR (May 9, 1983)
  • K823899 — INFANT CARE SYSTEM (April 14, 1983)
  • K830680 — AIR-SHIELDS VENTIMETER VENTILATOR-CONTR (April 8, 1983)

Other clearances for product code FMZ

  • K251619 — Babyleo TN500 (February 13, 2026)
  • K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
  • 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