The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Pulmonary Monitor.
| Device ID | K781922 |
| 510k Number | K781922 |
| Device Name: | PULMONARY MONITOR |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | VITALOGRAPH LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-13 |
| Decision Date | 1979-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35099169439970 | K781922 | 000 |
| 55099169430001 | K781922 | 000 |
| 35099169434005 | K781922 | 000 |
| 35099169436023 | K781922 | 000 |
| 35099169437037 | K781922 | 000 |
| 35099169438218 | K781922 | 000 |
| 55099169439004 | K781922 | 000 |
| 55099169439035 | K781922 | 000 |
| 55099169439509 | K781922 | 000 |
| 55099169439813 | K781922 | 000 |
| 35099169439833 | K781922 | 000 |
| 35099169439840 | K781922 | 000 |
| 35099169439918 | K781922 | 000 |
| 35099169439932 | K781922 | 000 |
| 55099169439110 | K781922 | 000 |