510(k) K990856

HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 by Bird Products Corp. — Product Code BZD

K990856 is an FDA 510(k) premarket notification submitted by Bird Products Corp. for the device "HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682". The FDA issued a decision of Substantially Equivalent on January 11, 2000. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Bird Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2000
Date Received
March 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type