|Recognition List Number: 010 FR Publication Date: 06/01/2004
Part B: Supplementary Information
Recognition Number 1-47: AS 4259-1995, ancillary devices for expired air resuscitation. (Anesthesias)
Date of Standard: 1995.
|Address of Standards Development Organization:|
| Standards Australia (AS)|
| 1 The Cresent|
| Homebush, 0 |
|CDRH Office and Division associated with recognized standards:|
|OFFICE OF DEVICE EVALUATION (ODE) |
|CPR facemasks and shields and non-breathing valves|
|Processes Affected: |
|510(K), Design Control Input|
|Type of Standard:|
| Vertical, International|
|Extent of Recognition:|
|The portions of the standard related to cpr masks and one-way valves are recognized with the following exceptions:
Clause 10.1 Table 3 is not recognized; refer to ASTM F 920-93 Table 1.
Clause 10.4 is not recognized; refer to ASTM F 920-93 Clause 7.4.
Clause 10.8 is not recognized; refer to ASTM F920-93 Clause 7.7.
Clause 10.16 is not standard relating to oropharyngeal and nasopharyngeal airways are not recognized.
|Related CFR Citations and Product Codes:|
|Relevant Guidance: |
|Draft Reviewer Guidance of Face Masks and Shields for CPR, March 16, 1994|
|FDA Technical Contact:|
| Christy Foreman |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1676 |
| Silver Spring MD 20993 |
| 301/796-6382 |
| email: email@example.com|