Home / 510(k) Clearances / K112547

510(k) K112547

NEO NEST by Denovo Proucts, LLC — Product Code IMD

K112547 is an FDA 510(k) premarket notification submitted by Denovo Proucts, LLC for the device "NEO NEST". The FDA issued a decision of Substantially Equivalent on March 6, 2012. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2012
Date Received
September 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Disposable
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type

Other clearances for product code IMD

  • K221653 — InfaTherm Disposable Infant Warming Mattress (October 6, 2022)
  • K163295 — Infant Transport Mattress Warmer with Disc (July 24, 2017)
  • K082087 — EYEFEEL OPHTHALMIC WARMER (September 11, 2008)
  • K071710 — BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) (August 14, 2007)
  • K021843 — EYEFEEL OPHTHALMIC WARMER (September 3, 2002)
  • K982652 — ALLEGIANCE PORTA-WARM MATTRESS (January 21, 1999)
  • K980509 — DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS (February 26, 1998)
  • K974190 — CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER (November 19, 1997)
  • K973770 — ALLEGIANCE KWIK HEAT WARM PERINEAL PACK (November 13, 1997)
  • K970399 — KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) (April 3, 1997)

FDA data resources