The following data is part of a premarket notification filed by Albahealth, L.l.c. with the FDA for Pulstar Logix Intermittent Pneumatic Compression System.
| Device ID | K123308 |
| 510k Number | K123308 |
| Device Name: | PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ALBAHEALTH, L.L.C. 425 NORTH GATEWAY AVE. Rockwood, TN 37854 |
| Contact | Patrick Frank |
| Correspondent | Patrick Frank ALBAHEALTH, L.L.C. 425 NORTH GATEWAY AVE. Rockwood, TN 37854 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-24 |
| Decision Date | 2013-02-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50073614780007 | K123308 | 000 |
| 50073614776925 | K123308 | 000 |
| 50073614776918 | K123308 | 000 |
| 50073614776901 | K123308 | 000 |
| 50073614776895 | K123308 | 000 |
| 50073614776888 | K123308 | 000 |
| 50073614776871 | K123308 | 000 |
| 50073614776864 | K123308 | 000 |
| 50073614776857 | K123308 | 000 |
| 50073614776833 | K123308 | 000 |
| 50073614776826 | K123308 | 000 |
| 50073614776772 | K123308 | 000 |
| 50073614762171 | K123308 | 000 |
| 50073614762164 | K123308 | 000 |
| 50073614762157 | K123308 | 000 |
| 50073614762140 | K123308 | 000 |
| 50073614755913 | K123308 | 000 |
| 50073614755852 | K123308 | 000 |
| 50073614776932 | K123308 | 000 |
| 50073614776949 | K123308 | 000 |
| 50073614779995 | K123308 | 000 |
| 50073614779988 | K123308 | 000 |
| 50073614779971 | K123308 | 000 |
| 50073614779964 | K123308 | 000 |
| 50073614779957 | K123308 | 000 |
| 50073614778998 | K123308 | 000 |
| 50073614778967 | K123308 | 000 |
| 50073614778950 | K123308 | 000 |
| 50073614777038 | K123308 | 000 |
| 50073614777021 | K123308 | 000 |
| 50073614777014 | K123308 | 000 |
| 50073614777007 | K123308 | 000 |
| 50073614776994 | K123308 | 000 |
| 50073614776987 | K123308 | 000 |
| 50073614776970 | K123308 | 000 |
| 50073614776963 | K123308 | 000 |
| 50073614776956 | K123308 | 000 |
| 50073614776840 | K123308 | 000 |