The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Pulmonary Function Filter.
| Device ID | K854062 |
| 510k Number | K854062 |
| Device Name: | PALL PULMONARY FUNCTION FILTER |
| Classification | Spirometer, Diagnostic |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Contact | Sidney Krakauer |
| Correspondent | Sidney Krakauer PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-04 |
| Decision Date | 1985-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35034480309144 | K854062 | 000 |