Home / 510(k) Clearances / K913220

510(k) K913220

AEROSOL MASKS, 81426, 81476, 81490 & 81492 by Specialty Packaging Producs, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1991
Date Received
July 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Specialty Packaging Producs, Inc.

  • K922492 — SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER (August 24, 1992)
  • K913163 — NON REBREATHING VALVE (February 3, 1992)
  • K913422 — OXYGEN TUBING, 81503 (January 30, 1992)
  • K913164 — NON REBREATHING MASK (January 15, 1992)
  • K913216 — TRACH T ADAPTER (January 15, 1992)
  • K913421 — NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (October 18, 1991)
  • K913383 — OXYGEN MASKS 81420, 81421, 81471 & 81461 (October 18, 1991)
  • K913275 — VENTURI OXYGEN MASK (October 10, 1991)
  • K913455 — OXYGEN MASKS 82400 & 82405 (October 2, 1991)
  • K910896 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT (May 8, 1991)

Other clearances for product code CAF

  • K251572 — eRapid with eTrack System (December 19, 2025)
  • K251659 — Mesh Nebulizer (H6) (November 14, 2025)
  • K244035 — Portable mesh nebulizer (JM821) (September 19, 2025)
  • K243468 — Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebul (July 2, 2025)
  • K250022 — HeroTracker Sense (June 30, 2025)
  • K250583 — AdheResp Smart Breath-actuated Mesh Nebulizer (June 20, 2025)
  • K242354 — AllNEB (April 29, 2025)
  • K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (June 18, 2024)
  • K232507 — Aerogen®Solo Nebulizer System (May 10, 2024)
  • K232523 — Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% (April 10, 2024)