The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Voluchek 6600.
| Device ID | K863656 |
| 510k Number | K863656 |
| Device Name: | SALTER VOLUCHEK 6600 |
| Classification | Spirometer, Diagnostic |
| Applicant | SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
| Contact | James N Curti |
| Correspondent | James N Curti SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-18 |
| Decision Date | 1986-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411600071 | K863656 | 000 |
| 10607411007580 | K863656 | 000 |
| 20607411007594 | K863656 | 000 |
| 10607411007603 | K863656 | 000 |
| 00607411600012 | K863656 | 000 |
| 00607411600036 | K863656 | 000 |
| 10607411600040 | K863656 | 000 |
| 00607411600050 | K863656 | 000 |
| 10607411600064 | K863656 | 000 |
| 10607411007566 | K863656 | 000 |