The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Dtx And Dtx Plus Disposable Pressure Transducers And Accessories.
Device ID | K935782 |
510k Number | K935782 |
Device Name: | DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | OHMEDA MEDICAL 1900 WILLIAMS DR. Oxnard, CA 93030 -2691 |
Contact | Cheryl L Shea |
Correspondent | Cheryl L Shea OHMEDA MEDICAL 1900 WILLIAMS DR. Oxnard, CA 93030 -2691 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-06 |
Decision Date | 1994-08-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884450388710 | K935782 | 000 |
20884450322783 | K935782 | 000 |
10884450330972 | K935782 | 000 |
10884450330859 | K935782 | 000 |
20884450371798 | K935782 | 000 |
00884450330777 | K935782 | 000 |
20884450360594 | K935782 | 000 |
20884450371842 | K935782 | 000 |
10884450331023 | K935782 | 000 |
00884450330982 | K935782 | 000 |
10884450330996 | K935782 | 000 |
20884450544154 | K935782 | 000 |
10884450330835 | K935782 | 000 |
20884450372788 | K935782 | 000 |
10884450330965 | K935782 | 000 |
20884450384248 | K935782 | 000 |
20884450374829 | K935782 | 000 |
20884450481114 | K935782 | 000 |
20884450323247 | K935782 | 000 |
20884450384187 | K935782 | 000 |
20884450435629 | K935782 | 000 |
20884450372948 | K935782 | 000 |
20884450371750 | K935782 | 000 |
20884450323117 | K935782 | 000 |
20884450372511 | K935782 | 000 |
20884450371873 | K935782 | 000 |
20884450322660 | K935782 | 000 |
20884450322622 | K935782 | 000 |
20884450373006 | K935782 | 000 |
20884450463851 | K935782 | 000 |
20884450385061 | K935782 | 000 |
20884450482531 | K935782 | 000 |
20884450371736 | K935782 | 000 |