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510(k) K980509

DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS by Deroyal Industries, Inc. — Product Code IMD

K980509 is an FDA 510(k) premarket notification submitted by Deroyal Industries, Inc. for the device "DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS". The FDA issued a decision of Substantially Equivalent on February 26, 1998. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. Deroyal Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1998
Date Received
February 10, 1998
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

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  • K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover (January 21, 2020)
  • K173072 — Algidex Ag Silver Alginate Wound Dressing (April 4, 2018)
  • K171475 — DeRoyal Laprador Specimen Retrieval System (August 17, 2017)
  • K152978 — DeRoyal Angiography Kits (March 25, 2016)

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)
  • K112547 — NEO NEST (March 6, 2012)
  • 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)
  • 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