The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Neonate Percussor.
| Device ID | K860510 |
| 510k Number | K860510 |
| Device Name: | NEONATE PERCUSSOR |
| Classification | Percussor, Powered-electric |
| Applicant | BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | E. M Chamberlain |
| Correspondent | E. M Chamberlain BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-11 |
| Decision Date | 1986-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10609038968671 | K860510 | 000 |