Panels › Anesthesiology › Product code BSJ · Class 1
Mask, Gas, Anesthetic
Regulation 868.5550
0510(k)s in 12 months (51 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in BSJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Medipart Jerry Alexander | 6 | 0 |
| Engineered Medical Systems | 2 | 1 |
| Life Design Systems, Inc. | 3 | 0 |
| Vital Signs, Inc. | 3 | 0 |
| Hans Rudolph, Inc. | 2 | 0 |
| Ohio Medical Products | 2 | 0 |
| Rondex Products, Inc. | 2 | 0 |
| Warne Surgical Products, Ltd. | 2 | 0 |
| Advanced Warming Systems, Inc. | 1 | 0 |
| Ambu, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2013 | Engineered Medical Systems,Inc Respironics SealFlex Single Port Ribbed Mask (Infant).
For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of th Terminated |
BSJ | K874746 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.