The following data is part of a premarket notification filed by Spirometrics, Inc. with the FDA for Spirometrics Model 2141 Spiro-filter(tm).
| Device ID | K884465 |
| 510k Number | K884465 |
| Device Name: | SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM) |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | SPIROMETRICS, INC. 33 OMNI CIRCLE Auburn, ME 04210 -1210 |
| Contact | G Cyr |
| Correspondent | G Cyr SPIROMETRICS, INC. 33 OMNI CIRCLE Auburn, ME 04210 -1210 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-24 |
| Decision Date | 1988-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855784004085 | K884465 | 000 |