The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Value Care Cuff Large Adult, Value Care Cuff Adult Xl (extra Long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult Nibp Airhose, 3 M, Efficia Adult Nibp Air Hose, 1.5 M.
| Device ID | K152363 |
| 510k Number | K152363 |
| Device Name: | Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra Long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M |
| Classification | Blood Pressure Cuff |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover, MA 03104 -1099 |
| Contact | Mary Kruitwagen |
| Correspondent | Mary Kruitwagen PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover, MA 03104 -1099 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-20 |
| Decision Date | 2015-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838048584 | K152363 | 000 |
| 00884838048577 | K152363 | 000 |
| 00884838048560 | K152363 | 000 |
| 00884838048553 | K152363 | 000 |
| 00884838048546 | K152363 | 000 |
| 00884838048539 | K152363 | 000 |