The following data is part of a premarket notification filed by Summit Medical Products, Inc with the FDA for Ambit Pca*pib, Ambit Pib, Ambit Pib*pca, Ambit Pieb, And Ambit Programmable Intermittent Pump.
| Device ID | K162165 |
| 510k Number | K162165 |
| Device Name: | AmbIT PCA*PIB, AmbIT PIB, AmbIT PIB*PCA, AmbIT PIEB, And AmbIT Programmable Intermittent Pump |
| Classification | Pump, Infusion, Pca |
| Applicant | SUMMIT MEDICAL PRODUCTS, INC 504 West 8360 South Sandy, UT 84070 |
| Contact | Levoy Haight |
| Correspondent | Levoy Haight SUMMIT MEDICAL PRODUCTS, INC 504 West 8360 South Sandy, UT 84070 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-03 |
| Decision Date | 2017-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20193494001180 | K162165 | 000 |
| 00193494001308 | K162165 | 000 |
| 20193494000770 | K162165 | 000 |
| 00193494001315 | K162165 | 000 |
| 00193494000707 | K162165 | 000 |
| 00193494000769 | K162165 | 000 |
| 00193494001216 | K162165 | 000 |
| 00193494001384 | K162165 | 000 |
| 20193494000381 | K162165 | 000 |
| 10193494001084 | K162165 | 000 |
| 10193494001091 | K162165 | 000 |
| 20193494001104 | K162165 | 000 |
| 10193494001114 | K162165 | 000 |
| 20193494001128 | K162165 | 000 |
| 10193494001145 | K162165 | 000 |
| 10193494001152 | K162165 | 000 |
| 20193494001166 | K162165 | 000 |
| 00193494001292 | K162165 | 000 |