The following data is part of a premarket notification filed by Clement Clarke Intl., Ltd. with the FDA for In-check Inspiratory Flowmeter.
| Device ID | K980960 |
| 510k Number | K980960 |
| Device Name: | IN-CHECK INSPIRATORY FLOWMETER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | CLEMENT CLARKE INTL., LTD. EDINBURGH WAY Harlow, GB Cm20 2tt |
| Contact | M J Wilkinson |
| Correspondent | M J Wilkinson CLEMENT CLARKE INTL., LTD. EDINBURGH WAY Harlow, GB Cm20 2tt |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-16 |
| Decision Date | 1998-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05023323001177 | K980960 | 000 |
| 05023323001153 | K980960 | 000 |
| 05023323001146 | K980960 | 000 |
| 05023323000897 | K980960 | 000 |
| 05023323000804 | K980960 | 000 |
| 05023323000408 | K980960 | 000 |
| 05023323000361 | K980960 | 000 |
| 05023323000354 | K980960 | 000 |