The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Precision Blender.
| Device ID | K053232 |
| 510k Number | K053232 |
| Device Name: | PRECISION BLENDER |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Contact | James Parker |
| Correspondent | James Parker PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-18 |
| Decision Date | 2006-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817770021445 | K053232 | 000 |
| 00853061006104 | K053232 | 000 |
| 00853061006111 | K053232 | 000 |
| 00853061006166 | K053232 | 000 |
| 00853061006173 | K053232 | 000 |
| 00853061006197 | K053232 | 000 |
| 00853061006203 | K053232 | 000 |
| 00853061006258 | K053232 | 000 |
| 00855887006009 | K053232 | 000 |
| 00855887006016 | K053232 | 000 |
| 00855887006061 | K053232 | 000 |
| 00817770021230 | K053232 | 000 |
| 00853061006098 | K053232 | 000 |