The following data is part of a premarket notification filed by Biolab Equipment Canada Ltd. with the FDA for Biopure Portable Ro System,biopure 4400 Series Ro System, Biopure 8400 Series Ro System,biopure Water Purfication Pretre.
| Device ID | K030348 |
| 510k Number | K030348 |
| Device Name: | BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE |
| Classification | Subsystem, Water Purification |
| Applicant | BIOLAB EQUIPMENT CANADA LTD. 128 GRANDVIEW AVE. Thornhill, Ontario, CA L3t 1h6 |
| Contact | Jerry Ponikvar |
| Correspondent | Jerry Ponikvar BIOLAB EQUIPMENT CANADA LTD. 128 GRANDVIEW AVE. Thornhill, Ontario, CA L3t 1h6 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-03 |
| Decision Date | 2003-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817492021327 | K030348 | 000 |
| 00817492021440 | K030348 | 000 |
| 00817492021457 | K030348 | 000 |
| 00817492021464 | K030348 | 000 |
| 00817492021471 | K030348 | 000 |
| 00817492021488 | K030348 | 000 |
| 00817492021495 | K030348 | 000 |
| 00817492021501 | K030348 | 000 |
| 00817492021518 | K030348 | 000 |
| 00817492021433 | K030348 | 000 |
| 00817492021426 | K030348 | 000 |
| 00817492021419 | K030348 | 000 |
| 00817492021334 | K030348 | 000 |
| 00817492021341 | K030348 | 000 |
| 00817492021358 | K030348 | 000 |
| 00817492021365 | K030348 | 000 |
| 00817492021372 | K030348 | 000 |
| 00817492021389 | K030348 | 000 |
| 00817492021396 | K030348 | 000 |
| 00817492021402 | K030348 | 000 |
| 00817492021525 | K030348 | 000 |
| 00817492021532 | K030348 | 000 |
| 00817492021655 | K030348 | 000 |
| 00817492021662 | K030348 | 000 |
| 00817492021679 | K030348 | 000 |
| 00817492021686 | K030348 | 000 |
| 00817492021778 | K030348 | 000 |
| 00817492021808 | K030348 | 000 |
| 00817492021860 | K030348 | 000 |
| 00817492021907 | K030348 | 000 |
| 00817492021648 | K030348 | 000 |
| 00817492021631 | K030348 | 000 |
| 00817492021624 | K030348 | 000 |
| 00817492021549 | K030348 | 000 |
| 00817492021556 | K030348 | 000 |
| 00817492021563 | K030348 | 000 |
| 00817492021570 | K030348 | 000 |
| 00817492021587 | K030348 | 000 |
| 00817492021594 | K030348 | 000 |
| 00817492021600 | K030348 | 000 |
| 00817492021617 | K030348 | 000 |
| 00817492021914 | K030348 | 000 |