The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Genx Coda Air Purification System.
| Device ID | K001486 |
| 510k Number | K001486 |
| Device Name: | GENX CODA AIR PURIFICATION SYSTEM |
| Classification | Accessory, Assisted Reproduction |
| Applicant | INTL., INC. 170 FORT PATH RD. UNIT 14 Madison, CT 06443 |
| Contact | Michael D Cecchi |
| Correspondent | Michael D Cecchi INTL., INC. 170 FORT PATH RD. UNIT 14 Madison, CT 06443 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-12 |
| Decision Date | 2000-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815965021539 | K001486 | 000 |
| 00815965021072 | K001486 | 000 |
| 00815965021157 | K001486 | 000 |
| 00815965021164 | K001486 | 000 |
| 00815965021171 | K001486 | 000 |
| 00815965021188 | K001486 | 000 |
| 00815965021577 | K001486 | 000 |
| 00815965021201 | K001486 | 000 |
| 00815965021218 | K001486 | 000 |
| 00815965021065 | K001486 | 000 |
| 00815965021058 | K001486 | 000 |
| 00815965021041 | K001486 | 000 |
| 00815965021515 | K001486 | 000 |
| 00815965021478 | K001486 | 000 |
| 00815965020969 | K001486 | 000 |
| 00815965021560 | K001486 | 000 |
| 00815965020983 | K001486 | 000 |
| 00815965020990 | K001486 | 000 |
| 00815965021003 | K001486 | 000 |
| 00815965021010 | K001486 | 000 |
| 00815965021249 | K001486 | 000 |
| 00815965021836 | K001486 | 000 |
| 00815965021638 | K001486 | 000 |
| 00815965021645 | K001486 | 000 |
| 00815965021690 | K001486 | 000 |
| 00815965021706 | K001486 | 000 |
| 00815965021713 | K001486 | 000 |
| 00815965021720 | K001486 | 000 |
| 00815965021843 | K001486 | 000 |
| 00815965021850 | K001486 | 000 |
| 00815965021621 | K001486 | 000 |
| 00815965021614 | K001486 | 000 |
| 00815965021508 | K001486 | 000 |
| 00815965021409 | K001486 | 000 |
| 00815965021416 | K001486 | 000 |
| 00815965021423 | K001486 | 000 |
| 00815965021430 | K001486 | 000 |
| 00815965021447 | K001486 | 000 |
| 00815965021454 | K001486 | 000 |
| 00815965021461 | K001486 | 000 |
| 00815965021492 | K001486 | 000 |
| 00815965022253 | K001486 | 000 |