The following data is part of a premarket notification filed by American Electromedics Corp. with the FDA for 629v Spirometer, Pulmonary Function Analyzer.
| Device ID | K881402 |
| 510k Number | K881402 |
| Device Name: | 629V SPIROMETER, PULMONARY FUNCTION ANALYZER |
| Classification | Spirometer, Diagnostic |
| Applicant | AMERICAN ELECTROMEDICS CORP. 13 SAGAMORE PARK RD. Hudson, NH 03051 |
| Contact | T. M Gleason |
| Correspondent | T. M Gleason AMERICAN ELECTROMEDICS CORP. 13 SAGAMORE PARK RD. Hudson, NH 03051 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-09-26 |