Recognition List Number: 010 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 Organization: |
| Standards Australia (AS) |
| 1 The Cresent |
| Homebush, 0 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| CPR facemasks and shields and non-breathing valves |
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| Processes Affected: |
| 510(K), Design Control Input |
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| 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. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5870 |
Valve, Non-Rebreathing |
Class 2 |
CBP |
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| Relevant Guidance: |
| Draft Reviewer Guidance of Face Masks and Shields for CPR, March 16, 1994 |
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| FDA Technical Contact: |
| Christy Foreman |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1676 |
| Silver Spring MD 20993 |
| 301/796-6382 |
| Email: christy.foreman@fda.hhs.gov |
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