Home / 510(k) Clearances / K863049

510(k) K863049

INHALATION AID by Boehringer Ingelheim Pharmaceuticals, Inc. — Product Code BYP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1986
Date Received
August 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthpiece, Breathing
Device Class
Class I
Regulation Number
868.5620
Review Panel
AN
Submission Type

Other clearances by Boehringer Ingelheim Pharmaceuticals, Inc.

  • K852277 — CATAPRESS TOURNIGUET (June 27, 1985)

Other clearances for product code BYP

  • K955657 — NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE (March 12, 1996)
  • K944512 — TRUZONE PFM DISPOSABLE MOUTHPIECE (November 2, 1994)
  • K893791 — BREATHING MOUTHPIECE (June 23, 1989)
  • K872037 — AEROCHAMBER (July 24, 1987)
  • K865093 — SAFE-T-SHIELD MOUTHPIECE (January 15, 1987)
  • K862788 — MP-4400 MOUTHPIECE-FLANGE SEAL (August 1, 1986)
  • K853575 — MEDIPART MOUTHPIECE MP-1010 (October 29, 1985)
  • K853574 — MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (October 29, 1985)
  • K853572 — MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 (October 29, 1985)
  • K853266 — PLASTIC MOUTH BARRIER HSV-I (October 29, 1985)