The following data is part of a premarket notification filed by Engineering, Inc. with the FDA for Lm2000a Surgical Suction Monitor.
| Device ID | K854359 |
| 510k Number | K854359 |
| Device Name: | LM2000A SURGICAL SUCTION MONITOR |
| Classification | Bottle, Collection, Vacuum |
| Applicant | ENGINEERING, INC. 214 LINCOLN CENTER DR. Foster City, CA 94404 |
| Contact | Gregory A Hatfield |
| Correspondent | Gregory A Hatfield ENGINEERING, INC. 214 LINCOLN CENTER DR. Foster City, CA 94404 |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-29 |
| Decision Date | 1986-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10859898006383 | K854359 | 000 |
| 00859898006096 | K854359 | 000 |
| 00385640067959 | K854359 | 000 |
| 10385640057612 | K854359 | 000 |