The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Posi-pulse Suction Unit.
| Device ID | K861261 |
| 510k Number | K861261 |
| Device Name: | OHMEDA POSI-PULSE SUCTION UNIT |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Contact | Douglas D Carden |
| Correspondent | Douglas D Carden OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-04 |
| Decision Date | 1986-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628101609245 | K861261 | 000 |
| 00628101609221 | K861261 | 000 |