510(k) K863049
K863049 is an FDA 510(k) premarket notification submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the device "INHALATION AID". The FDA issued a decision of Substantially Equivalent on October 15, 1986. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Boehringer Ingelheim Pharmaceuticals, Inc. has at least 1 other 510(k) clearance on record.
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