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510(k) K061071

V-808 ATOM TRANSCAPSULE by Atom Medical, Inc. — Product Code FPL

K061071 is an FDA 510(k) premarket notification submitted by Atom Medical, Inc. for the device "V-808 ATOM TRANSCAPSULE". The FDA issued a decision of Substantially Equivalent on August 29, 2006. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Atom Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2006
Date Received
April 17, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal Transport
Device Class
Class II
Regulation Number
880.5410
Review Panel
HO
Submission Type

Other clearances by Atom Medical, Inc.

  • K061856 — V-2200 INFANT INCUBATOR (September 28, 2006)
  • K060461 — V-505 INFA WARMER (April 28, 2006)
  • K021809 — V-2100G ADVANCED INFANT INCUBATOR (July 18, 2002)
  • K002355 — ATOM INFA WARMER V-505 (October 10, 2000)

Other clearances for product code FPL

  • K220742 — NxtGen Infant Transport Incubator (July 15, 2022)
  • K161918 — SREE MRI Transport Incubator (March 3, 2017)
  • K141565 — GLOBE-TROTTER GT5400 (September 10, 2014)
  • K123937 — ATOM TRANSCAPSULE V-707 (May 23, 2013)
  • K103525 — A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103524 — VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WIT (April 15, 2011)
  • K103527 — AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WIT (April 15, 2011)
  • K081399 — AVIATOR TRANSPORT INCUBATOR (June 6, 2008)
  • K062052 — LMT NOMAG IC 3.0 (July 31, 2006)

FDA data resources