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510(k) K820640

HOO2D SEAT-INFANT by Dhd Medical Products Div. Diemolding Corp. — Product Code BYL

K820640 is an FDA 510(k) premarket notification submitted by Dhd Medical Products Div. Diemolding Corp. for the device "HOO2D SEAT-INFANT". The FDA issued a decision of Substantially Equivalent on March 26, 1982. The device falls under product code BYL (Tent, Oxygen), a Class I device regulated under 21 CFR 868.5700. Dhd Medical Products Div. Diemolding Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1982
Date Received
March 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tent, Oxygen
Device Class
Class I
Regulation Number
868.5700
Review Panel
AN
Submission Type

Other clearances by Dhd Medical Products Div. Diemolding Corp.

  • K883988 — NON-REBREATHING TEE PIECE (NRTP) (October 7, 1988)
  • K881935 — MICROCIRRUS MEDICAL NEBULIZER (June 22, 1988)
  • K881178 — CUFFCHECK (April 14, 1988)
  • K873498 — INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING (March 9, 1988)
  • K874047 — ASTHMAKIT (February 29, 1988)
  • K873447 — DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (October 30, 1987)
  • K860878 — BRITISH BREATHING CIRCUIT SYSTEM (March 20, 1986)
  • K860885 — STRAIGHT CONNECTORS, 15MM, 30MM & 19MM (March 20, 1986)
  • K860882 — DISPOSABLE CATHETER (March 20, 1986)
  • K860877 — FLEXTUBE, CONNECTING TUBING (March 20, 1986)

Other clearances for product code BYL

  • K935126 — NASCOR IGLOO (October 18, 1994)
  • K905627 — NASCOR OXYDOME (June 3, 1991)
  • K896608 — SPAG PAK (April 9, 1990)
  • K895866 — DIRD INGANT O2 (BIO 2 HOOD) (October 27, 1989)
  • K893714 — KEYSTONE OXYGEN TENT (August 21, 1989)
  • K893713 — NOVA OXYGEN TENT (August 21, 1989)
  • K882396 — AEROSOL DELIVERY HOOD (August 1, 1988)
  • K851666 — MEDI-COMP NEONATAL OXYGEN HOOD (August 6, 1985)
  • K852345 — SEA-LONG NECKSEAL & HOOD (June 20, 1985)
  • K802653 — MEDIUM SIZE OXYGEN HOOD #1547 (November 24, 1980)

FDA data resources