The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph-alpha.
Device ID | K873562 |
510k Number | K873562 |
Device Name: | VITALOGRAPH-ALPHA |
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 | 1987-09-02 |
Decision Date | 1988-08-29 |