Device Classification Name |
heater, breathing system w/wo controller (not humidifier or nebulizer
|
510(k) Number |
K173280 |
Device Name |
Neonatal ConchaSmart Breathing Circuits |
Applicant |
Teleflex Medical, Inc |
3015 Carrington Mill Blvd-6N |
Morrisville,
NC
27560
|
|
Applicant Contact |
Brian Gall |
Correspondent |
Teleflex Medical, Inc |
3015 Carrington Mill Blvd-6N |
Morrisville,
NC
27560
|
|
Correspondent Contact |
Brian Gall |
Regulation Number | 868.5270
|
Classification Product Code |
|
Date Received | 10/16/2017 |
Decision Date | 08/02/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|