The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Models: Ircrf5, Ircpf16 Flowmeter Accessory Kits.
| Device ID | K914488 |
| 510k Number | K914488 |
| Device Name: | MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS |
| Classification | Generator, Oxygen, Portable |
| Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-08 |
| Decision Date | 1992-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447100157 | K914488 | 000 |
| 00850018761291 | K914488 | 000 |