The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph Compact.
| Device ID | K854526 |
| 510k Number | K854526 |
| Device Name: | VITALOGRAPH COMPACT |
| Classification | Spirometer, Diagnostic |
| Applicant | VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Lovina G Freeman |
| Correspondent | Lovina G Freeman VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-13 |
| Decision Date | 1985-12-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05099169678019 | K854526 | 000 |